<h3>Job Description</h3>
Job Description
We are looking for a Clinical Trials Project Manager II to join our team!
APPLY DIRECTLY at <a href="https://cpcclinicalresearch.org/careers/" target="_blank">https://cpcclinicalresearch.org/careers/</a> (internal title Clinical Operations Manager II)
Are you well organized, but adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day-to-day tasks? If the answer is yes, keep reading!
This role serves as the primary point of contact for industry sponsored clinical trials and Endpoint and Specialty Services activities.
In this position you will:
<ul>
<li>Oversee clinical operations management activities</li>
<li>Define and monitor project scope, timelines and deliverables from project initiation to close-out.</li>
<li>Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation.</li>
<li>Oversee trial-related activities.</li>
<li>Track and approve vendor payments.</li>
<li>Provide expert advice in the design, writing and/or review of all project-related essential documents including protocols, project management plans, case report forms, statistical analysis plans, project management plans, ICF templates, study procedure manuals, source documents, site newsletters, study reports, resource tools, essential documents, monitoring plans and report templates.</li>
<li>Develop and manage multidisciplinary project team members. Organize, plan for, and produce minutes for project team meetings.</li>
<li>Ensure the overall quality of project services and deliverables.</li>
<li>Provide necessary updates and reports to the sponsor as outlined by the contract.</li>
<li>Plan and oversee the execution of investigator meetings as contracted.</li>
<li>Work with the Business Development team on budgets, proposals and change orders.</li>
<li>Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact.</li>
<li>Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper.</li>
<li>Adhere to local, federal and international regulations, guidelines and CPC Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs). Use appropriate discretion to proactively identify when there is a need to deviate from policies, procedures or plans and ensure deviations are appropriately documented.</li>
<li>Define and monitor Endpoint and Specialty Services scope, timelines and deliverables from project initiation to closeout with assistance from study assigned Clinical Operations Manager and the Head of Endpoint and Specialty Services.</li>
<li>Manage contracted deliverables for external committees (e.g. data safety monitoring boards, clinical endpoint committees), including but not limited to meeting scheduling, generation of meeting minutes and distribution of meeting materials.</li>
<li>Oversee SAE process and assure execution of safety plans.</li>
<li>Accurately track receipt, entry, upload and the processing of photos, acetate tracings, and other source documents submitted from sites.</li>
<li>Contact appropriate individuals (e.g., study site staff or study site Clinical Research Associate) regarding incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required by the project.</li>
<li>Oversee timely and accurate entry and cleaning of data for all study databases; maintain and file data management documentation as required.</li>
<li>Provide feedback to study sites on tracing and quality issues, as required by project.</li>
<li>Manage and conduct Endpoint and Specialty Services CPC Core Lab activities.</li>
<li>Provide operational support for the biostatistics and programming deliverables.</li>
</ul>
Here’s what you will need to bring to the table:
<ul>
<li>Nursing or BA/BS in a scientific field (or equivalent knowledge/experience).</li>
<li>4 years of experience in a clinical research setting, including a minimum of 2 years of project/operations management experience in clinical research (required).</li>
<li>Demonstrated ability to adequately manage all facets of a clinical trial with minimal direction.</li>
<li>Thorough knowledge of the Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials.</li>
<li>Proficiency in Microsoft Office, particularly Outlook, Word and Excel.</li>
<li>Excellent communication and organizational skills.</li>
<li>Great attention to detail.</li>
<li>Exemplary skills leading and managing multi-disciplinary teams in a clinical research setting.</li>
<li>Ability to organize, instruct and oversee project staff, while promoting group effort and achievement.</li>
<li>Ability to adapt quickly to new situations, manage conflicts and resolve problems effectively.</li>
<li>Willingness to travel 20-25%.</li>
</ul>
Note: Viable applicants will be required to pass a background and education verification check.
Targeted Compensation: $72,000 – $95,000 annually
Company DescriptionAbout CPC: CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 35 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials. CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. <a href="http://www.cpccommunityhealth.org/" target="_blank">http://www.cpccommunityhealth.org/</a> CPC offers: * Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) * Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately) * 11 paid holidays * 15 - 25 vacation days based on years of service * Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) * In-suite exercise and relaxation room * Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics) * Flexible and remote work schedules available for certain positions Visit our web site to learn more about us and values we embrace: <a href="https://cpcclinicalresearch.org/" target="_blank">https://cpcclinicalresearch.org/</a>. An Equal Opportunity Employer CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at <a href="mailto:careers@cpcmed.org" target="_blank">careers@cpcmed.org</a>. 
<h3>Company Description</h3>
About CPC:\r\nCPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 35 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. \r\n\r\nCPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.\r\n\r\nCPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. <a href="http://www.cpccommunityhealth.org/" target="_blank">http://www.cpccommunityhealth.org/</a> \r\n\r\nCPC offers:\r\n* Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)\r\n* Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)\r\n* 11 paid holidays\r\n* 15 - 25 vacation days based on years of service\r\n* Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) \r\n* In-suite exercise and relaxation room\r\n* Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)\r\n* Flexible and remote work schedules available for certain positions\r\n\r\nVisit our web site to learn more about us and values we embrace: <a href="https://cpcclinicalresearch.org/" target="_blank">https://cpcclinicalresearch.org/</a>.\r\n\r\nAn Equal Opportunity Employer\r\nCPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.\r\n\r\nApplicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at <a href="mailto:careers@cpcmed.org" target="_blank">careers@cpcmed.org</a>.

Clinical Trials Project Manager II - remote

<h3>Job Description</h3>
Job Description
Job Title: Clinical Study Manager
Job Location: Boston, MA, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
 By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description: Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team. At Takeda, we are transforming the pharmaceutical industry through our R&amp;D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. Here, you will be a necessary contributor to our inspiring, bold mission. GOALS : Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan. In close collaboration with Clinical Operations Program Lead(s) 
<ul>
<li>Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.</li>
<li>Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives. </li>
</ul>
The assigned clinical studies may be of low to medium level of complexity. More than one study and/or more than one program may be assigned. A:CCOUNTABILITIES : 
<ul>
<li>Accountable for planning and operational strategy and execution for assigned clinical trials.</li>
<li>Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents.</li>
<li>Challenges study team to ensure operational feasibility, inclusive of patient and site burden.</li>
<li>Validates budget and ensures impacts are adequately addressed.</li>
<li>Participates in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy.</li>
<li>Challenges study team to ensure timelines meet the needs of the clinical development plan.</li>
<li>Ensure new team members and vendors are appropriately onboarded.</li>
<li>During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place.</li>
<li>Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly.</li>
<li>Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs.</li>
<li>Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted.</li>
<li>Specific areas of sponsor oversight include, but are not limited to</li>
<li>Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring.</li>
<li>Review and endorsement of relevant study plans, as applicable.</li>
<li>Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes.</li>
<li>Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study.</li>
<li>Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies.</li>
<li>In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR.</li>
<li>Ensure studies are “inspection ready” at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections. </li>
</ul>
EDUCATION AND EXPERIENCE : 
<ul>
<li>BS/BA required, preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experience.</li>
<li>Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements.</li>
<li>5 or more years’ experience in pharmaceutical industry and/or clinical research organization, including 3 or more years clinical study management/oversight, including significant study management support experience (e.g. clinical trial assistant/associate or lead CRA).</li>
<li>Experience could include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.</li>
<li>Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.</li>
<li>Demonstrated successful experience in project/program management and matrix leadership.</li>
<li>Good communication skills.</li>
<li>Excellent teamwork, organizational, interpersonal, and problem-solving skills.</li>
<li>Fluent business English (oral and written). </li>
</ul>
Takeda Compensation and Benefits Summary: We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Massachusetts - Virtual U.S. Base Salary Range : $99,500.00 - $156,420.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement: Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations: Massachusetts - Virtual Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time Job Exempt: Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. 
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Clinical Study Manager

<h3>Job Description</h3>
Job Description
Clinical Data Manager
This position is based in St. Louis, Missouri, with a hybrid onsite and remote work schedule at the Geneoscopy office.
The Clinical Trial Data Manager is responsible for managing clinical data to support regulatory submissions and product development. This role ensures the accuracy, integrity, and quality of clinical data in compliance with Good Clinical Practice (GCP) and applicable regulatory guidelines.
 
RESPONSIBILITIES
<ul>
<li>Design, review, and approve essential documents and databases, including informed consent forms (ICFs), case report forms (CRFs), and study protocols.</li>
<li>Collaborate with cross-functional teams to define data collection strategies.</li>
<li>Develop and maintain Data Management Plans (DMPs).</li>
<li>Liaise with external partners and internal teams to ensure data integrity and timely delivery.</li>
<li>Monitor data entry for consistency, completeness, and compliance with study protocols.</li>
<li>Implement appropriate systems, standards, and processes to maintain clinical study files per applicable guidance.</li>
<li>Ensure that trials are conducted in compliance with applicable regulations and internal policies, and procedures.</li>
<li>Provide regular updates on study progress to senior leadership and other stakeholders; proactively identify and resolve issues that arise during study conduct; and manage the escalation of study-related issues.</li>
<li>Oversee the clinical aspects of timely data cleaning, data analysis, and the availability of top-line results, participate in data reviews, and review statistical analysis plans.</li>
<li>Author, edit, and/or review written summaries of data reports, presentations, training material, and study documents.</li>
<li>Coordinate with Quality Assurance to ensure internal and external study team members are trained on the appropriate policies and procedures.</li>
<li>Prepare clinical trial reports, regulatory submissions, and support audits or inspections as needed.</li>
<li>Participate in audits and inspections as needed.</li>
<li>Manage and develop a team of Clinical Research Associates (CRAs).</li>
<li>Other duties as assigned.</li>
</ul>
 
EDUCATION REQUIREMENTS
<ul>
<li>Bachelor's degree in Life Sciences, or related field.
<ul>
<li>Master's degree preferred.</li>
</ul>
</li>
</ul>
 
QUALIFICATIONS
<ul>
<li>Possess 5+ years of experience in clinical data management, preferably within a CRO, pharmaceutical, or biotech environment.</li>
<li>Exemplify thorough knowledge of applicable regulations.</li>
<li>Possess strong experience with the management of CROs and other vendors.</li>
<li>Demonstrate strong knowledge of protocol, processes, clinical study design, study planning and management, and monitoring.</li>
<li>Possess the ability to solve complex problems, apply judgment, and make clear recommendations.</li>
<li>Exemplify the ability to multitask and thrive in an agile, fast-paced, deadline-driven environment while remaining flexible, proactive, resourceful, and efficient.</li>
<li>Possess proficient verbal and written communication skills, while willing to share and receive information and ideas from all levels of the organization to achieve the desired results.</li>
<li>Possess high ethics and conduct business in the most professional manner.</li>
<li>Seek inclusiveness and collaboration but step up to responsibility, make tough decisions, and be accountable for those decisions.</li>
<li>Act as a results-oriented team player with strong interpersonal and communication skills, capable of working collaboratively with colleagues.</li>
</ul>
 
SCHEDULE This is a salaried position, requiring at least 40 hours per week. There may be projects that require activities beyond the standard hours.
This role will require travel up to 25%.
 
COMPENSATION &amp; BENEFITS
<ul>
<li>Base salary range: $130,000 - 150,000/annually determined based on the candidate's experience, knowledge, and abilities.</li>
<li>Bonus: discretionary annual bonus based on a percentage of the employee's base salary</li>
<li>Benefits: health, vision, dental, life insurance, 401k (with employer match), and paid time off.</li>
<li>Company Stock Options</li>
</ul>
 
ADDITIONAL INFORMATION
Geneoscopy's Core Values Ability to embody Geneoscopy's beliefs, philosophies, and principles:
<ul>
<li>Integrity - we do the right thing through our words, actions, and behaviors</li>
<li>Courage - step up, speak up, stand out</li>
<li>Agility - think and act fast, embracing change</li>
<li>Passion - for our customers, our people, our work, and for excellence</li>
<li>Collaboration - our differences are assets</li>
</ul>
 Physical Demands
<ul>
<li>Employees may be required to lift routine office supplies and use standard office equipment.</li>
<li>Must possess the ability to sit and/or stand for long periods.</li>
<li>Must possess the ability to perform repetitive motion.</li>
</ul>
 Work Environment
<ul>
<li>May have exposure to fumes and bio-hazardous material in the laboratory environment.</li>
<li>May be required to handle blood-borne pathogens and general laboratory reagents.</li>
</ul>
 
By completing this online employment application, you certify that the information on this application is true and complete to the best of your knowledge. You understand that any misrepresentation or omission of fact in response to any inquiry made in this application may result in the rejection of the application or if hired, dismissal whenever it is discovered. You authorize and release all parties from any liability or damage that may result from seeking, furnishing, or using such information. You understand and agree that, if hired, your employment is for no definite period and may, regardless of the date of payment of compensation, be terminated by Geneoscopy at any time, for any or no reason, with or without notice. You understand that no representation to the contrary is valid unless in writing, setting a definite term of employment, and signed by the company's CEO. You further understand and agree that any job offer is contingent upon your passing, to the company's satisfaction, a criminal background check, reference checks, and other possible screenings. You understand that this application is active for 90 days only, and if you do not hear from the company but still wish to be considered for employment after 90 days, you will need to fill out a new application.

Clinical Data Manager

<h3>Job Description</h3>
Job DescriptionSalary: $150-175k 
About SpyGlass Pharma:
 
At SpyGlass Pharma, we are focused on improving and preserving the vision of patients suffering from chronic eye conditions, while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common causes of blindness and getting these products to the patients that need them.

We have built a team of driven professionals with diverse expertise in ophthalmic products and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology and a history of commercial success. Our unifying mantra, We create for patients doesnt just live on our walls but drives our decision making as we build the company, creating the products, processes and culture that make it happen.

This team has delivered a solid foundation of development and clinical data, enabling over $120 million in funding to date with several top-tier venture partners. We are building confidence in the performance of our lead product going into Phase 3 clinical trials.
 
Summary:
 
SpyGlass Pharma is seeking a strong, hands-on leader to manage and mentor our national team of Clinical Application Specialists (CASs). This leadership role combines team management, strategic planning, and field deployment with the technical proficiency required to support our novel sustained-release drug delivery platform for cataract surgery.
The Manager will oversee hiring, training, and performance management for the CAS team, while also coordinating field assignments and ensuring each CAS is confident, consistent, and effective in supporting surgeons and clinical staff. This is a collaborative position requiring operational oversight, coaching ability, and a strong understanding of cataract surgical flow, in-OR support, and clinic education.
Ideal candidates will bring both leadership experience and hands-on clinical applications background within ophthalmology and must be comfortable operating in FDA-regulated environments, including clinical trial sites
Please note:This is a U.S. based, remote position that requires regular travel to clinical trial sites across the country (up to 70%). Applicants must be currently authorized to work in the United States and comfortable with a travel-based schedule.
 
Essential Duties and Responsibilities:
<ul>
<li>Lead, mentor, and manage a national team of Clinical Application Specialists (CASs), including hiring, training, and performance evaluations.</li>
<li>Assign and coordinate CAS coverage for clinical trial sites, early commercial adopters, and high-priority engagements.</li>
<li>Support professional development of CASs through ride-alongs, coaching, and ongoing skills assessments.</li>
<li>Make sure CASs maintain proficiency in the SpyGlass drug delivery system, including proper assembly, delivery, and troubleshooting.</li>
<li>Demonstrate and teach CASs how to effectively support surgeons and staff within the OR and in clinics.</li>
<li>Ensure team alignment with FDA, GCP, and company compliance requirements in all field activity.</li>
<li>Collaborate with Clinical Operations, R&amp;D, and Commercial to translate field feedback into actionable insights.</li>
<li>Oversee consistency of onboarding and procedural support delivered by CASs to surgeons, OR personnel, and clinic staff.</li>
<li>Represent the CAS team and field perspective at investigator meetings, internal training sessions, and industry events. </li>
</ul>
 
Qualifications Required for Position:
<ul>
<li>Bachelors degree in life sciences, nursing, biomedical engineering, or related field; advanced degree or surgical credentialing preferred.</li>
<li>10+ years of experience in clinical applications, surgical support, or device educationpreferably in ophthalmology or cataract surgery.</li>
<li>Minimum 2 years in a leadership role managing field-based teams, including hiring, mentoring, and territory planning.</li>
<li>Deep understanding of cataract surgical flow, with ability to observe and guide every step of the procedure.</li>
<li>Demonstrated success training others on device use, in-theater presence, and clinic workflow integration.</li>
<li>Comfort operating within FDA-regulated environments and knowledge of clinical trial site requirements.</li>
<li>Strong interpersonal and communication skills, with the ability to lead and inspire both field staff and internal partners.</li>
<li>Proficiency in Microsoft Office and clinical documentation platforms. </li>
</ul>
 
Why SpyGlass Pharma?
<ul>
<li>We are offering a range of $150,000 - $175,000, based on experience and qualifications, along with an Annual Bonus opportunity.</li>
<li>Share in our success with stock options, giving you a stake in the companys future.</li>
<li>Comprehensive health, dental, and vision insurance plans to keep you and your family healthy and happy, with a variety of plan and coverage options.</li>
<li>Generous paid time off, including holidays, vacation days, and personal leave.</li>
</ul>
SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. 

SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to <a href="mailto:JOBS@SPYGLASSPHARMA.COM" target="_blank">JOBS@SPYGLASSPHARMA.COM</a> and let us know the nature of your request and your contact information.
 remote work

Clinical Applications Specialist, Manager

<h3>Job Description</h3>
Job Description
Job Title: Senior Clinical Data Manager - JJMT Neurovascular
Job Location: Fargo, ND, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: 
 At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at <a href="https://www.jnj.com" target="_blank">https://www.jnj.com</a> Job Function Data Analytics &amp; Computational Sciences Job Sub Function Clinical Data Management Job Category Professional All Job Posting Locations: Albuquerque, New Mexico, United States of America, Albuquerque, New Mexico, United States of America, Anchorage, Alaska, United States, Atlanta, Georgia, United States, Austin, Texas, United States, Birmingham, Alabama, United States, Boise, Idaho, United States, Boulder, Colorado, United States, Burlington, Vermont, United States, Charleston, South Carolina, United States, Chicago, Illinois, United States, Concord, New Hampshire, United States, Detroit, Michigan, United States, Fargo, North Dakota, United States, Gulfport, Mississippi, United States, Honolulu, Hawaii, United States, Irvine, California, United States of America, Kansas City, Kansas, United States, Kansas City, Missouri, United States, Knoxville, Tennessee, United States, Las Vegas, Nevada, United States, Lexington, Kentucky, United States, Lincoln, Nebraska, United States, Little Rock, Arkansas, United States, Minneapolis, Minnesota, United States of America {+ 9 more} Job Description Johnson &amp; Johnson MedTech – Neurovascular division is currently seeking a Sr. Clinical Data Manager. This position is a remote position. At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at <a href="https://www.jnj.com/medtech/" target="_blank">https://www.jnj.com/medtech/</a> Summary The Senior Clinical Data Manager will be responsible for all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects with minimal supervision. S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets. Position Duties &amp; Responsibilities Reporting to the Manager, Data Management this individual will: 
<ul>
<li>Support CRF design, review and validation of clinical database, including supporting management of CRO activities in this area if required;</li>
<li>Have the ability to support a number of moderate complexity / complex trials with minimal supervision;</li>
<li>Be responsible for creation of data management plans and other data management documentation as needed with minimal oversight;</li>
<li>Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines;</li>
<li>Be responsible for coordinating, facilitating and participating in all data management activities from initiation of protocol through database lock with minimal oversight, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects;</li>
<li>Be responsible for participating in ongoing data review throughout the conduct of the study, including being responsible for the correction of errors and discrepancies management for the life of a project;</li>
<li>Proactively identify and address issues that may impact the quality of the data, deliverables or timelines;</li>
<li>Be responsible for handling of non-CRF data, including lab data and image handling;</li>
<li>Be responsible for coordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed;</li>
<li>Contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with data management leadership as needed;</li>
<li>Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner;</li>
<li>Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times;</li>
<li>Diligently participate in compliance program-related activities as denoted by the supervisor or our Chief Compliance Officer;</li>
<li>Performs other related duties as required. </li>
</ul>
Functional And Technical Competencies 
<ul>
<li>Therapeutic area knowledge in at least one of orthopedics, gynecology, cardiovascular, or general surgery.</li>
<li>Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc.).</li>
<li>Strong verbal and written communication skills.</li>
<li>Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software.</li>
<li>Experience with Electronic Data Capture (EDC), Medidata RAVE preferred. Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug). </li>
</ul>
Leadership Competencies 
<ul>
<li>Connect - Cultivate relationships with key internal stakeholders to ensure projects remain on target to project timelines.</li>
<li>Shape – Develop knowledge of therapeutic areas within the Franchises.</li>
<li>Lead – Active participation as data management representative on project teams to ensure deliverables are met.</li>
<li>Deliver – ensure projects are delivered on time, within budget and in compliance to regulations and SOPs. </li>
</ul>
Requirements 
<ul>
<li>A Bachelor’s degree (or equivalent) in the biological sciences, Computer Science or related discipline.</li>
<li>At least 4 years of clinical data management experience in Medical Device or Pharmaceuticals.</li>
<li>Experience of supporting trials with minimal supervision. </li>
</ul>
he anticipated base pay range for this position is $89,000 - $143,750 
<ul>
<li>The Company maintains a highly competitive sales incentive compensation program. Under current guidelines, this position is eligible for participation in this program in accordance with the terms of the applicable plan. </li>
<li>This position is eligible for a car allowance through the Company’s Fleet program.</li>
<li>Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. </li>
</ul>
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). 
<ul>
<li> This position is eligible to participate in the Company’s long-term incentive program.</li>
<li> Employees are eligible for the following time off benefits:</li>
<li> Vacation – up to 120 hours per calendar year</li>
<li> Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year</li>
<li> Holiday pay, including Floating Holidays – up to 13 days per calendar year</li>
<li> Work, Personal and Family Time - up to 40 hours per calendar year </li>
</ul>
Additional information can be found through the link below.  <a href="https://www.careers.jnj.com/employee-benefits" target="_blank">https://www.careers.jnj.com/employee-benefits</a> Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is : $89,000 - $143,750 Additional Description For Pay Transparency The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. <a href="http://www.careers.jnj.com/employee-benefits" target="_blank">http://www.careers.jnj.com/employee-benefits</a> 
This job is curated by Lifelancer.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

Senior Clinical Data Manager - JJMT Neurovascular

<h3>Job Description</h3>
Job Description
Job Title: Senior Clinical Data Manager - JJMT Neurovascular
Job Location: Albuquerque, NM, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: 
 At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at <a href="https://www.jnj.com" target="_blank">https://www.jnj.com</a> Job Function Data Analytics &amp; Computational Sciences Job Sub Function Clinical Data Management Job Category Professional All Job Posting Locations: Albuquerque, New Mexico, United States of America, Albuquerque, New Mexico, United States of America, Anchorage, Alaska, United States, Atlanta, Georgia, United States, Austin, Texas, United States, Birmingham, Alabama, United States, Boise, Idaho, United States, Boulder, Colorado, United States, Burlington, Vermont, United States, Charleston, South Carolina, United States, Chicago, Illinois, United States, Concord, New Hampshire, United States, Detroit, Michigan, United States, Fargo, North Dakota, United States, Gulfport, Mississippi, United States, Honolulu, Hawaii, United States, Irvine, California, United States of America, Kansas City, Kansas, United States, Kansas City, Missouri, United States, Knoxville, Tennessee, United States, Las Vegas, Nevada, United States, Lexington, Kentucky, United States, Lincoln, Nebraska, United States, Little Rock, Arkansas, United States, Minneapolis, Minnesota, United States of America {+ 9 more} Job Description Johnson &amp; Johnson MedTech – Neurovascular division is currently seeking a Sr. Clinical Data Manager. This position is a remote position. At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at <a href="https://www.jnj.com/medtech/" target="_blank">https://www.jnj.com/medtech/</a> Summary The Senior Clinical Data Manager will be responsible for all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects with minimal supervision. S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets. Position Duties &amp; Responsibilities Reporting to the Manager, Data Management this individual will: 
<ul>
<li>Support CRF design, review and validation of clinical database, including supporting management of CRO activities in this area if required;</li>
<li>Have the ability to support a number of moderate complexity / complex trials with minimal supervision;</li>
<li>Be responsible for creation of data management plans and other data management documentation as needed with minimal oversight;</li>
<li>Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines;</li>
<li>Be responsible for coordinating, facilitating and participating in all data management activities from initiation of protocol through database lock with minimal oversight, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects;</li>
<li>Be responsible for participating in ongoing data review throughout the conduct of the study, including being responsible for the correction of errors and discrepancies management for the life of a project;</li>
<li>Proactively identify and address issues that may impact the quality of the data, deliverables or timelines;</li>
<li>Be responsible for handling of non-CRF data, including lab data and image handling;</li>
<li>Be responsible for coordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed;</li>
<li>Contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with data management leadership as needed;</li>
<li>Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner;</li>
<li>Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times;</li>
<li>Diligently participate in compliance program-related activities as denoted by the supervisor or our Chief Compliance Officer;</li>
<li>Performs other related duties as required. </li>
</ul>
Functional And Technical Competencies 
<ul>
<li>Therapeutic area knowledge in at least one of orthopedics, gynecology, cardiovascular, or general surgery.</li>
<li>Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc.).</li>
<li>Strong verbal and written communication skills.</li>
<li>Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software.</li>
<li>Experience with Electronic Data Capture (EDC), Medidata RAVE preferred. Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug). </li>
</ul>
Leadership Competencies 
<ul>
<li>Connect - Cultivate relationships with key internal stakeholders to ensure projects remain on target to project timelines.</li>
<li>Shape – Develop knowledge of therapeutic areas within the Franchises.</li>
<li>Lead – Active participation as data management representative on project teams to ensure deliverables are met.</li>
<li>Deliver – ensure projects are delivered on time, within budget and in compliance to regulations and SOPs. </li>
</ul>
Requirements 
<ul>
<li>A Bachelor’s degree (or equivalent) in the biological sciences, Computer Science or related discipline.</li>
<li>At least 4 years of clinical data management experience in Medical Device or Pharmaceuticals.</li>
<li>Experience of supporting trials with minimal supervision. </li>
</ul>
he anticipated base pay range for this position is $89,000 - $143,750 
<ul>
<li>The Company maintains a highly competitive sales incentive compensation program. Under current guidelines, this position is eligible for participation in this program in accordance with the terms of the applicable plan. </li>
<li>This position is eligible for a car allowance through the Company’s Fleet program.</li>
<li>Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. </li>
</ul>
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). 
<ul>
<li> This position is eligible to participate in the Company’s long-term incentive program.</li>
<li> Employees are eligible for the following time off benefits:</li>
<li> Vacation – up to 120 hours per calendar year</li>
<li> Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year</li>
<li> Holiday pay, including Floating Holidays – up to 13 days per calendar year</li>
<li> Work, Personal and Family Time - up to 40 hours per calendar year </li>
</ul>
Additional information can be found through the link below.  <a href="https://www.careers.jnj.com/employee-benefits" target="_blank">https://www.careers.jnj.com/employee-benefits</a> Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is : $89,000 - $143,750 Additional Description For Pay Transparency The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. <a href="http://www.careers.jnj.com/employee-benefits" target="_blank">http://www.careers.jnj.com/employee-benefits</a> 
This job is curated by Lifelancer.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

<h3>Job Description</h3>
Job Description
Job Title: Senior Clinical Data Manager - JJMT Neurovascular
Job Location: Kansas City, KS, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: 
 At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at <a href="https://www.jnj.com" target="_blank">https://www.jnj.com</a> Job Function Data Analytics &amp; Computational Sciences Job Sub Function Clinical Data Management Job Category Professional All Job Posting Locations: Albuquerque, New Mexico, United States of America, Albuquerque, New Mexico, United States of America, Anchorage, Alaska, United States, Atlanta, Georgia, United States, Austin, Texas, United States, Birmingham, Alabama, United States, Boise, Idaho, United States, Boulder, Colorado, United States, Burlington, Vermont, United States, Charleston, South Carolina, United States, Chicago, Illinois, United States, Concord, New Hampshire, United States, Detroit, Michigan, United States, Fargo, North Dakota, United States, Gulfport, Mississippi, United States, Honolulu, Hawaii, United States, Irvine, California, United States of America, Kansas City, Kansas, United States, Kansas City, Missouri, United States, Knoxville, Tennessee, United States, Las Vegas, Nevada, United States, Lexington, Kentucky, United States, Lincoln, Nebraska, United States, Little Rock, Arkansas, United States, Minneapolis, Minnesota, United States of America {+ 9 more} Job Description Johnson &amp; Johnson MedTech – Neurovascular division is currently seeking a Sr. Clinical Data Manager. This position is a remote position. At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at <a href="https://www.jnj.com/medtech/" target="_blank">https://www.jnj.com/medtech/</a> Summary The Senior Clinical Data Manager will be responsible for all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects with minimal supervision. S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets. Position Duties &amp; Responsibilities Reporting to the Manager, Data Management this individual will: 
<ul>
<li>Support CRF design, review and validation of clinical database, including supporting management of CRO activities in this area if required;</li>
<li>Have the ability to support a number of moderate complexity / complex trials with minimal supervision;</li>
<li>Be responsible for creation of data management plans and other data management documentation as needed with minimal oversight;</li>
<li>Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines;</li>
<li>Be responsible for coordinating, facilitating and participating in all data management activities from initiation of protocol through database lock with minimal oversight, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects;</li>
<li>Be responsible for participating in ongoing data review throughout the conduct of the study, including being responsible for the correction of errors and discrepancies management for the life of a project;</li>
<li>Proactively identify and address issues that may impact the quality of the data, deliverables or timelines;</li>
<li>Be responsible for handling of non-CRF data, including lab data and image handling;</li>
<li>Be responsible for coordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed;</li>
<li>Contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with data management leadership as needed;</li>
<li>Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner;</li>
<li>Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times;</li>
<li>Diligently participate in compliance program-related activities as denoted by the supervisor or our Chief Compliance Officer;</li>
<li>Performs other related duties as required. </li>
</ul>
Functional And Technical Competencies 
<ul>
<li>Therapeutic area knowledge in at least one of orthopedics, gynecology, cardiovascular, or general surgery.</li>
<li>Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc.).</li>
<li>Strong verbal and written communication skills.</li>
<li>Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software.</li>
<li>Experience with Electronic Data Capture (EDC), Medidata RAVE preferred. Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug). </li>
</ul>
Leadership Competencies 
<ul>
<li>Connect - Cultivate relationships with key internal stakeholders to ensure projects remain on target to project timelines.</li>
<li>Shape – Develop knowledge of therapeutic areas within the Franchises.</li>
<li>Lead – Active participation as data management representative on project teams to ensure deliverables are met.</li>
<li>Deliver – ensure projects are delivered on time, within budget and in compliance to regulations and SOPs. </li>
</ul>
Requirements 
<ul>
<li>A Bachelor’s degree (or equivalent) in the biological sciences, Computer Science or related discipline.</li>
<li>At least 4 years of clinical data management experience in Medical Device or Pharmaceuticals.</li>
<li>Experience of supporting trials with minimal supervision. </li>
</ul>
he anticipated base pay range for this position is $89,000 - $143,750 
<ul>
<li>The Company maintains a highly competitive sales incentive compensation program. Under current guidelines, this position is eligible for participation in this program in accordance with the terms of the applicable plan. </li>
<li>This position is eligible for a car allowance through the Company’s Fleet program.</li>
<li>Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. </li>
</ul>
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). 
<ul>
<li> This position is eligible to participate in the Company’s long-term incentive program.</li>
<li> Employees are eligible for the following time off benefits:</li>
<li> Vacation – up to 120 hours per calendar year</li>
<li> Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year</li>
<li> Holiday pay, including Floating Holidays – up to 13 days per calendar year</li>
<li> Work, Personal and Family Time - up to 40 hours per calendar year </li>
</ul>
Additional information can be found through the link below.  <a href="https://www.careers.jnj.com/employee-benefits" target="_blank">https://www.careers.jnj.com/employee-benefits</a> Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is : $89,000 - $143,750 Additional Description For Pay Transparency The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. <a href="http://www.careers.jnj.com/employee-benefits" target="_blank">http://www.careers.jnj.com/employee-benefits</a> 
This job is curated by Lifelancer.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

<h3>Job Description</h3>
Job Description
Job Title: Senior Clinical Data Manager - JJMT Neurovascular
Job Location: Charleston, SC, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: 
 At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at <a href="https://www.jnj.com" target="_blank">https://www.jnj.com</a> Job Function Data Analytics &amp; Computational Sciences Job Sub Function Clinical Data Management Job Category Professional All Job Posting Locations: Albuquerque, New Mexico, United States of America, Albuquerque, New Mexico, United States of America, Anchorage, Alaska, United States, Atlanta, Georgia, United States, Austin, Texas, United States, Birmingham, Alabama, United States, Boise, Idaho, United States, Boulder, Colorado, United States, Burlington, Vermont, United States, Charleston, South Carolina, United States, Chicago, Illinois, United States, Concord, New Hampshire, United States, Detroit, Michigan, United States, Fargo, North Dakota, United States, Gulfport, Mississippi, United States, Honolulu, Hawaii, United States, Irvine, California, United States of America, Kansas City, Kansas, United States, Kansas City, Missouri, United States, Knoxville, Tennessee, United States, Las Vegas, Nevada, United States, Lexington, Kentucky, United States, Lincoln, Nebraska, United States, Little Rock, Arkansas, United States, Minneapolis, Minnesota, United States of America {+ 9 more} Job Description Johnson &amp; Johnson MedTech – Neurovascular division is currently seeking a Sr. Clinical Data Manager. This position is a remote position. At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at <a href="https://www.jnj.com/medtech/" target="_blank">https://www.jnj.com/medtech/</a> Summary The Senior Clinical Data Manager will be responsible for all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects with minimal supervision. S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets. Position Duties &amp; Responsibilities Reporting to the Manager, Data Management this individual will: 
<ul>
<li>Support CRF design, review and validation of clinical database, including supporting management of CRO activities in this area if required;</li>
<li>Have the ability to support a number of moderate complexity / complex trials with minimal supervision;</li>
<li>Be responsible for creation of data management plans and other data management documentation as needed with minimal oversight;</li>
<li>Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines;</li>
<li>Be responsible for coordinating, facilitating and participating in all data management activities from initiation of protocol through database lock with minimal oversight, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects;</li>
<li>Be responsible for participating in ongoing data review throughout the conduct of the study, including being responsible for the correction of errors and discrepancies management for the life of a project;</li>
<li>Proactively identify and address issues that may impact the quality of the data, deliverables or timelines;</li>
<li>Be responsible for handling of non-CRF data, including lab data and image handling;</li>
<li>Be responsible for coordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed;</li>
<li>Contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with data management leadership as needed;</li>
<li>Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner;</li>
<li>Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times;</li>
<li>Diligently participate in compliance program-related activities as denoted by the supervisor or our Chief Compliance Officer;</li>
<li>Performs other related duties as required. </li>
</ul>
Functional And Technical Competencies 
<ul>
<li>Therapeutic area knowledge in at least one of orthopedics, gynecology, cardiovascular, or general surgery.</li>
<li>Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc.).</li>
<li>Strong verbal and written communication skills.</li>
<li>Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software.</li>
<li>Experience with Electronic Data Capture (EDC), Medidata RAVE preferred. Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug). </li>
</ul>
Leadership Competencies 
<ul>
<li>Connect - Cultivate relationships with key internal stakeholders to ensure projects remain on target to project timelines.</li>
<li>Shape – Develop knowledge of therapeutic areas within the Franchises.</li>
<li>Lead – Active participation as data management representative on project teams to ensure deliverables are met.</li>
<li>Deliver – ensure projects are delivered on time, within budget and in compliance to regulations and SOPs. </li>
</ul>
Requirements 
<ul>
<li>A Bachelor’s degree (or equivalent) in the biological sciences, Computer Science or related discipline.</li>
<li>At least 4 years of clinical data management experience in Medical Device or Pharmaceuticals.</li>
<li>Experience of supporting trials with minimal supervision. </li>
</ul>
he anticipated base pay range for this position is $89,000 - $143,750 
<ul>
<li>The Company maintains a highly competitive sales incentive compensation program. Under current guidelines, this position is eligible for participation in this program in accordance with the terms of the applicable plan. </li>
<li>This position is eligible for a car allowance through the Company’s Fleet program.</li>
<li>Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. </li>
</ul>
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). 
<ul>
<li> This position is eligible to participate in the Company’s long-term incentive program.</li>
<li> Employees are eligible for the following time off benefits:</li>
<li> Vacation – up to 120 hours per calendar year</li>
<li> Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year</li>
<li> Holiday pay, including Floating Holidays – up to 13 days per calendar year</li>
<li> Work, Personal and Family Time - up to 40 hours per calendar year </li>
</ul>
Additional information can be found through the link below.  <a href="https://www.careers.jnj.com/employee-benefits" target="_blank">https://www.careers.jnj.com/employee-benefits</a> Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is : $89,000 - $143,750 Additional Description For Pay Transparency The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. <a href="http://www.careers.jnj.com/employee-benefits" target="_blank">http://www.careers.jnj.com/employee-benefits</a> 
This job is curated by Lifelancer.
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<h3>Job Description</h3>
Job Description
Job Title: Senior Clinical Data Manager - JJMT Neurovascular
Job Location: Lexington, KY, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: 
 At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at <a href="https://www.jnj.com" target="_blank">https://www.jnj.com</a> Job Function Data Analytics &amp; Computational Sciences Job Sub Function Clinical Data Management Job Category Professional All Job Posting Locations: Albuquerque, New Mexico, United States of America, Albuquerque, New Mexico, United States of America, Anchorage, Alaska, United States, Atlanta, Georgia, United States, Austin, Texas, United States, Birmingham, Alabama, United States, Boise, Idaho, United States, Boulder, Colorado, United States, Burlington, Vermont, United States, Charleston, South Carolina, United States, Chicago, Illinois, United States, Concord, New Hampshire, United States, Detroit, Michigan, United States, Fargo, North Dakota, United States, Gulfport, Mississippi, United States, Honolulu, Hawaii, United States, Irvine, California, United States of America, Kansas City, Kansas, United States, Kansas City, Missouri, United States, Knoxville, Tennessee, United States, Las Vegas, Nevada, United States, Lexington, Kentucky, United States, Lincoln, Nebraska, United States, Little Rock, Arkansas, United States, Minneapolis, Minnesota, United States of America {+ 9 more} Job Description Johnson &amp; Johnson MedTech – Neurovascular division is currently seeking a Sr. Clinical Data Manager. This position is a remote position. At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at <a href="https://www.jnj.com/medtech/" target="_blank">https://www.jnj.com/medtech/</a> Summary The Senior Clinical Data Manager will be responsible for all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects with minimal supervision. S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets. Position Duties &amp; Responsibilities Reporting to the Manager, Data Management this individual will: 
<ul>
<li>Support CRF design, review and validation of clinical database, including supporting management of CRO activities in this area if required;</li>
<li>Have the ability to support a number of moderate complexity / complex trials with minimal supervision;</li>
<li>Be responsible for creation of data management plans and other data management documentation as needed with minimal oversight;</li>
<li>Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines;</li>
<li>Be responsible for coordinating, facilitating and participating in all data management activities from initiation of protocol through database lock with minimal oversight, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects;</li>
<li>Be responsible for participating in ongoing data review throughout the conduct of the study, including being responsible for the correction of errors and discrepancies management for the life of a project;</li>
<li>Proactively identify and address issues that may impact the quality of the data, deliverables or timelines;</li>
<li>Be responsible for handling of non-CRF data, including lab data and image handling;</li>
<li>Be responsible for coordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed;</li>
<li>Contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with data management leadership as needed;</li>
<li>Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner;</li>
<li>Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times;</li>
<li>Diligently participate in compliance program-related activities as denoted by the supervisor or our Chief Compliance Officer;</li>
<li>Performs other related duties as required. </li>
</ul>
Functional And Technical Competencies 
<ul>
<li>Therapeutic area knowledge in at least one of orthopedics, gynecology, cardiovascular, or general surgery.</li>
<li>Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc.).</li>
<li>Strong verbal and written communication skills.</li>
<li>Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software.</li>
<li>Experience with Electronic Data Capture (EDC), Medidata RAVE preferred. Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug). </li>
</ul>
Leadership Competencies 
<ul>
<li>Connect - Cultivate relationships with key internal stakeholders to ensure projects remain on target to project timelines.</li>
<li>Shape – Develop knowledge of therapeutic areas within the Franchises.</li>
<li>Lead – Active participation as data management representative on project teams to ensure deliverables are met.</li>
<li>Deliver – ensure projects are delivered on time, within budget and in compliance to regulations and SOPs. </li>
</ul>
Requirements 
<ul>
<li>A Bachelor’s degree (or equivalent) in the biological sciences, Computer Science or related discipline.</li>
<li>At least 4 years of clinical data management experience in Medical Device or Pharmaceuticals.</li>
<li>Experience of supporting trials with minimal supervision. </li>
</ul>
he anticipated base pay range for this position is $89,000 - $143,750 
<ul>
<li>The Company maintains a highly competitive sales incentive compensation program. Under current guidelines, this position is eligible for participation in this program in accordance with the terms of the applicable plan. </li>
<li>This position is eligible for a car allowance through the Company’s Fleet program.</li>
<li>Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. </li>
</ul>
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). 
<ul>
<li> This position is eligible to participate in the Company’s long-term incentive program.</li>
<li> Employees are eligible for the following time off benefits:</li>
<li> Vacation – up to 120 hours per calendar year</li>
<li> Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year</li>
<li> Holiday pay, including Floating Holidays – up to 13 days per calendar year</li>
<li> Work, Personal and Family Time - up to 40 hours per calendar year </li>
</ul>
Additional information can be found through the link below.  <a href="https://www.careers.jnj.com/employee-benefits" target="_blank">https://www.careers.jnj.com/employee-benefits</a> Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is : $89,000 - $143,750 Additional Description For Pay Transparency The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. <a href="http://www.careers.jnj.com/employee-benefits" target="_blank">http://www.careers.jnj.com/employee-benefits</a> 
This job is curated by Lifelancer.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

<h3>Job Description</h3>
Job Description
Summary
The Clinical Data Manager will be responsible for the oversight and management of clinical trial data specifically related to In Vitro Diagnostics (IVD) studies. This role involves working closely with cross-functional teams to ensure data accuracy and compliance, managing databases, and supporting the clinical development of diagnostic devices. The Clinical Data Manager will ensure that all data collected during IVD trials is robust, reliable, and compliant with regulatory standards, with a specific focus on leveraging Veeva systems for data management. This position will be remote, full-time reporting to the Associate Director of Data Management.
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
<ol>
<li>Data Management Planning:
<ol>
<li>Develop and implement comprehensive Data Management Plans (DMPs) tailored to the unique needs of IVD studies, including diagnostic assay performance and clinical utility.</li>
<li>Collaborate with the project team to define database specifications, including eCRF design and database setup in the context of IVD trials, using Veeva Vault CDMS.</li>
<li>Ensure that data collection methods are optimized for the specific requirements of IVD clinical trials, such as handling large volumes of assay data and ensuring traceability of diagnostic results.</li>
</ol>
</li>
<li>Database Management:
<ol>
<li>Oversee the setup, testing, and maintenance of clinical trial databases, ensuring they are configured to handle complex IVD data structures.</li>
<li>Ensure databases are compliant with IVD-specific regulatory requirements (e.g., IVDR in Europe, FDA 21 CFR Part 820), with a focus on the integrity and traceability of diagnostic data.</li>
</ol>
</li>
<li>Data Collection and Validation:
<ol>
<li>Coordinate data entry, data cleaning, and validation processes for IVD trials, ensuring that diagnostic data, including test results, sample data, and calibration details, are accurately captured and verified.</li>
<li>Perform quality checks and resolve data discrepancies, with particular attention to the technical validity of diagnostic data and its correlation with clinical outcomes.</li>
<li>Monitor data entry progress and ensure timely completion, leveraging the EDC reporting tools.</li>
</ol>
</li>
<li>Data Analysis and Reporting:
<ol>
<li>Generate and review data listings, summaries, and reports.</li>
<li>Assist in the preparation of data for statistical analysis, ensuring that all diagnostic data is appropriately formatted for regulatory submissions.</li>
<li>Provide support for interim and final database locks, ensuring that diagnostic data is fully validated and ready for analysis.</li>
</ol>
</li>
<li>Documentation and Compliance:
<ol>
<li>Ensure all data management documentation is accurate, complete, and compliant with SOPs, clients and regulatory requirements.</li>
</ol>
</li>
<li>Cross-Functional Collaboration:
<ol>
<li>Work closely with biostatistics, clinical operations, regulatory, and IT teams to ensure seamless data management processes tailored to IVD trials.</li>
<li>Act as the primary point of contact for data management activities with external vendors and stakeholders.</li>
</ol>
</li>
<li>Training and Support:
<ol>
<li>Train clinical site staff on data management procedures, software, and specifically on Veeva Vault CDMS, with a focus on the nuances of IVD data.</li>
<li>Provide ongoing support and troubleshooting for data-related issues, particularly those related to the management of diagnostic data. </li>
</ol>
</li>
</ol>
Required Education and Experience
<ol>
<li>Bachelor’s degree in life sciences, medical technology, bioinformatics, computer science, or a related field. Advanced degree preferred.</li>
<li>Minimum of 3-5 years of experience in clinical data management, with a strong preference for experience in the IVD or medical device industry.</li>
<li>Experience working in a CRO environment with a focus on IVD studies is highly desirable.</li>
</ol>
Knowledge and Skills
<ol>
<li>Technical Skills:
<ol>
<li>Proficiency in clinical data management systems (e.g., Medidata, Oracle Clinical, REDCap) with specific experience in Veeva Vault CDMS is preferred</li>
<li>Strong understanding of regulatory requirements specific to IVD products (e.g., FDA 21 CFR Part 820, IVDR, CLIA).</li>
<li>Familiarity with programming languages (e.g., SAS, SQL) is a plus.</li>
</ol>
</li>
<li>Soft Skills:
<ol>
<li>Excellent organizational and time management skills.</li>
<li>Strong attention to detail and problem-solving abilities.</li>
<li>Effective communication and interpersonal skills. </li>
</ol>
</li>
</ol>
Supervisory Responsibility
This position may have supervisory responsibilities in future.
Why Join Us:
<ul>
<li>Be part of a cutting-edge biotech company that is making a real impact in life sciences.</li>
<li>Collaborate with leading scientists and professionals in the field.</li>
<li>Competitive salary, benefits, and career advancement opportunities.</li>
<li>A fast-paced and innovative environment with a focus on growth and development.</li>
</ul>
This role is a fantastic opportunity for an experienced CDM professional to contribute to an industry that is improving health outcomes worldwide.

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