<h3>Job Description</h3>
Job DescriptionSalary: $72,000 - $95,000 
We are looking for an experienced Clinical Operations Manager II to join our team! 
 
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, Endpoint and Specialty Services activities and also provides operational support for biostatistics and programming deliverables.
 
Remote candidates are welcome to apply.
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>
 
Heres 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, preferably with at least 2 years of project/operations management experience in clinical research.</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
 
Deadline to Apply: August 1, 2025
About 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:
<ul>
<li>Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)</li>
<li>Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)</li>
<li>11 paid holidays</li>
<li>15 - 25 vacation days based on years of service</li>
<li>Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)</li>
<li>In-suite exercise and relaxation room</li>
<li>Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)</li>
<li>Flexible and remote work schedules</li>
</ul>
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>.
 remote work

Clinical Operations Manager II

<h3>Job Description</h3>
Job Description
This is a remote position.
The Clinical Data Manager (CDM) is responsible for the oversight, integrity, and quality of clinical trial data from collection through database lock. The CDM ensures that data is accurate, consistent, and meets regulatory and protocol-specific requirements. This role collaborates closely with cross-functional teams, including Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs, to support timely and compliant study execution. Key Responsibilities: Design and review Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems to ensure accurate and complete data capture aligned with the study protocol. Develop and maintain data management plans (DMPs), data validation specifications, and CRF completion guidelines. Oversee data cleaning activities, including the generation, review, and resolution of data queries in collaboration with clinical sites and study teams. Perform ongoing data reviews to identify trends, inconsistencies, or protocol deviations. Ensure adherence to data standards (e.g., CDISC, SDTM) and regulatory requirements (e.g., FDA, ICH-GCP). Manage database lock activities and contribute to the preparation of clinical study reports (CSRs). Serve as the primary point of contact for data management vendors and oversee their deliverables. Participate in study team meetings and provide status updates related to data quality and timelines. Support audit readiness and participate in regulatory inspections when required. Minimum Qualifications: Bachelor’s degree in Life Sciences, Computer Science, Health Informatics, or related field. Advanced degree is a plus. Minimum of 3–5 years of experience in clinical data management within a pharmaceutical, biotech, or CRO environment. Proficiency in EDC platforms (e.g., Medidata Rave, Oracle InForm, Veeva, REDCap). Strong understanding of ICH-GCP, FDA regulations, and CDISC standards. Experience with data listings, query management, edit check programming, and coding dictionaries (e.g., MedDRA, WHODrug). Excellent organizational, analytical, and problem-solving skills. Strong communication and collaboration skills across cross-functional teams. Experience working on global, multi-site clinical trials preferred. In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth. E-Verify Participation: Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.

Clinical Data Manager

<h3>Job Description</h3>
Job Description
Clinical Project Manager
 
This position is based in St. Louis, Missouri, with a hybrid onsite and remote work schedule at the Geneoscopy office.
 
The Clinical Project Manager will oversee the planning, implementation, and execution of clinical trials. They will also ensure that studies are conducted in accordance with regulatory requirements, study protocols, timelines, and budgets. The Clinical Project Manager will act as the primary liaison between cross-functional teams and suppliers.
 
RESPONSIBILITIES
<ul>
<li>Manage all aspects of clinical trials from start-up to close-out, including planning, execution, monitoring, and reporting.</li>
<li>Develop and maintain detailed study project plans, timelines, budgets, procedures, staffing requirements, allotment of available resources, and risk mitigation strategies.</li>
<li>Coordinate clinical study timelines with applicable teams to meet critical milestones; escalate issues that may jeopardize timelines and deliverables.</li>
<li>Oversee day-to-day clinical trial activities, including site management and enrollment tracking.</li>
<li>Manage external suppliers.</li>
<li>Participate in site visits, monitoring oversight, and resolution of site issues.</li>
<li>Ensure that trials are conducted in compliance with applicable regulations, internal policies, and procedures.</li>
<li>Implement appropriate systems, standards, and processes to ensure trials are conducted in compliance with applicable regulations and internal policies and procedures.</li>
<li>Facilitate cross-functional team meetings, ensuring that team meetings have structure and clear purposes and goals; facilitate and drive meetings effectively, and clearly communicate decisions and action items to team members and relevant parties outside of the team.</li>
<li>Provide regular updates on study progression to senior leadership and other stakeholders; proactively identify and resolve issues that arise during the study; manage the escalation of study-related issues.</li>
<li>Coordinate with Quality Assurance to ensure internal and external study team members are trained on the appropriate policies and procedures.</li>
<li>Guide teams through the effective development, management approval, and execution of strategic plans for assigned studies; this includes ensuring risk management plans are fully developed, contracts are agreed upon and adhered to, change control procedures are followed, communication within and external to the team are effective, duties, responsibilities, and scopes of authority are properly assigned, and approved team resources are appropriately planned and managed.</li>
<li>Develop and manage clinical trial budgets and track against spending forecasts.</li>
<li>Provide mentoring and technical oversight to team members.</li>
<li>Ensure the efficient use of resources and escalate where adjustments are needed.</li>
<li>Participate in audits and inspections as needed.</li>
<li>Other duties as assigned.</li>
</ul>
 
EDUCATION REQUIREMENTS
<ul>
<li>Bachelor's degree in Life Sciences, or related field.</li>
</ul>
 
QUALIFICATIONS
<ul>
<li>Possess 5+ years of clinical research experience, including 2+ years in a project management role.</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 trial 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 Project Manager

<h3>Job Description</h3>
Job Description
Name: Manager, Clinical Outsourcing
Type: Staffing
Status: Pending
Start: 07/21/2025
End: 01/21/2026
Location:
Cambridge, MA
45 Sidney Street,
Schedule:
Start Date: 07/21/2025
Estimated End Date: 01/21/2026
Hours Per Week: 40.00
Hours Per Day: 8.00
Interview Notes: remote role
Description:
Reason: Peak Period
Department: Clinical Operations
Job Category: Clinical
Job Title: Manager, Clinical Outsourcing
Duties: This position reports into the Associate Director of Clinical Outsourcing. The right candidate will possess an understanding of Clinical Outsourcing activities for successful execution and lifecycle management of multiple clinical trials primarily in oncology and hematology indications in various phases of development.
Responsibilities of this position involve the day-to-day management of issuing Request For Proposals (RFPs), review of proposals, selection of key study vendors, and management of change orders for the company's clinical trials in collaboration with a dynamic Clinical Development team.
● Assists teams in the identification of potential vendors and CROs for clinical trial execution
● Collaboratively creates and issues Request for Proposals (RFPs), compiles responses and facilitates team review of proposals from clinical trial vendors
● Performs competitive bid analysis and derives recommendation to operational team leads
● Participates in pricing negotiations for CROs, Central Laboratories, Imaging, ePRO and other critical study vendors
● Leads and facilitates cross functional review vendor selection meetings
● Leads the contracting activities including facilitating the review of MSA and amendments, development of Work Orders, Change Order notifications and Change Orders to ensure appropriate pricing and timely execution
● Supports he development of Outsourcing processes and tools
● Assists with benchmarking analysis
● Collaborates effectively with all key functions including Clinical Operations, Finance, Legal, Biostatistics, PV, QA, Data Management, and Clinical Development to ensure appropriate stakeholder engagement in vendor selection and management.
● Identifies and seeks efficiency in vendor contracting to ensure improved value for service
● Assists in maintaining a central database of contract tracking and delivery of metrics
What basic qualifications do we require?
● Minimum Education Required: Bachelor's degree in scientific or business discipline.
● 2 + years in vendor and contract management with a sponsor company or CRO managing various phase clinical trials.
What additional qualifications are we seeking?
● Understanding of the drug development process
● Experience with vendor selection (conducting RFPs, proposal review, and budget negotiations)
● Experience with vendor oversight
● Experience in contracts, legal agreements, and financial budgeting/reconciliation preferred
● Experience in RFP procurement software a plus
● Motivated self-starter who can work in a fast-paced environment
● Creative problem solver with good communication and written skills
● Strong interpersonal and organizational skills are needed, with a high degree of attention to detail
● Proficient with the MS Office Suite especially Excel
● Ability to work with minimal direction
Company DescriptionIT Mantra, LLC. is a Certified Woman / Minority (WBE/MBE) owned company founded in 2003 and based in Massachusetts. We provide a comprehensive range of IT and Professional Staffing and Workforce Solutions that include contract, contract to hire and direct hire placement services as well Employer of Record (EOR) services nationally and specialize in the placement of women and diverse personnel. 
<h3>Company Description</h3>
IT Mantra, LLC. is a Certified Woman / Minority (WBE/MBE) owned company founded in 2003 and based in Massachusetts. We provide a comprehensive range of IT and Professional Staffing and Workforce Solutions that include contract, contract to hire and direct hire placement services as well Employer of Record (EOR) services nationally and specialize in the placement of women and diverse personnel.

Manager, Clinical Outsourcing

<h3>Job Description</h3>
Job Description
About Scientia Vascular: 
Our mission is to save lives. Scientia Vascular is a leading innovator and manufacturer of endovascular medical devices. We use micromachining and microfabrication processes to manufacture products that provide physicians with enhanced performance for optimal outcomes for their patients.
 
Job Position Summary:
The Clinical Affairs Manager (hereafter: “CA Manager”) is responsible for generating clinical evidence for regulatory submissions, post market surveillance, and marketing claims along with performing activities necessary to comply with global regulation, primarily in the United States and the European Union. Specifically, the CA Manager will help identify and coordinate clinical needs and run clinical studies, along with working to obtain regulatory approvals for new devices in development and helping to maintain approvals for Scientia Vascular’s portfolio of marketed devices. The CA Manager will also offer guidance generally on clinical and regulatory matters. 
Primary Responsibilities
 
Clinical Affairs:
<ul>
<li>Oversee overall strategy and process of compliance and management of clinical evidence generation</li>
<li>Generate clinical evidence for regulatory submissions, post market surveillance, and marketing claims</li>
<li>Run clinical studies according to ICH and GCP standards and ensure Scientia is in compliance with regulations for human subject protection</li>
<li>Coordinate inter-departmentally to understand clinical evidence needs and project scope, lead study design, generate cost proposals and timelines, and manage study execution</li>
<li>Identify and contract with sites and physicians </li>
<li>Write protocols, data collection forms/case report forms, consent documents, and other study related documents and route them through the Scientia quality system and IRB review (as necessary)</li>
<li>Manage external consultants or clinical KOLS to support clinical evidence generation</li>
<li>Coordinate with external collaborators to design, run, and report on clinical studies</li>
<li>Set up and maintain a Trial Master File for studies that need it</li>
<li>Generate training for study personnel and travel to participating sites</li>
<li>Perform site initiation, monitoring, and close out visits, along with necessary remote monitoring for studies as required </li>
<li>Write and maintain all Quality System procedures related to clinical evidence generation</li>
<li>Support and coordinate the preparation and submission of global regulatory filings</li>
<li>Assist with the maintenance of global product registrations</li>
<li>Comfortable with communication and interfacing with regulatory authorities</li>
<li>Review labelling and marketing materials to ensure alignment with current clinical evidence</li>
</ul>
Requirements/Qualifications:
<ul>
<li>BA/BS degree in Science, Engineering, Math or related field of study or equivalent</li>
<li>Minimum of 3 years of experience in medical device clinical affairs role</li>
<li>History of IRB communication, clinical writing (protocol, ICF, CRF, etc.), and TMF creation and maintenance</li>
<li>Experience performing site qualification, initiation, monitoring, and close out</li>
<li>History of authoring or contributing to successful 510(k), PMA, and/or CE Mark submissions</li>
<li>Demonstrated ability to interpret and apply relevant regulations, standards and guidance to ongoing company activities</li>
<li>Computer proficiency with Adobe, Microsoft Word, and Excel</li>
<li>Excellent analysis, writing, and communication skills</li>
<li>Ability to communicate with cross-functional teams</li>
<li>Demonstrate knowledge of a clinical and regulated environment</li>
<li>Progressive CA leadership experience, including “hands-on” quality systems development</li>
<li>Strong background in analyzing and interpreting clinical trial data</li>
</ul>
Preferred Experience:
<ul>
<li>Experience managing a team of people</li>
<li>Advanced degree (MS, PhD, or PharmD</li>
<li>experience contributing to successful regulatory submissions</li>
<li>Familiarity with risk-based monitoring, adaptive trial design, or decentralized trials</li>
<li>History of publishing in academic journals</li>
<li>Ability to understand technical documents and drawings</li>
</ul>
Key benefits we provide: 
<ul>
<li>Medical, Dental, Vision insurance</li>
<li>Generous Paid Time Off (PTO) </li>
<li>Paid Parental Leave </li>
<li>Paid Holidays</li>
<li>401k Plan (with a generous employer match) </li>
<li>Life Insurance (company paid) </li>
<li>Short-Term &amp; Long-Term Disability Insurance (company paid) </li>
<li>Subscription to Calm.com </li>
<li>Employee Assistance Program </li>
<li>An environment of belonging where everyone can thrive</li>
</ul>
Commitment to Equal Opportunity:
The Scientia Vascular culture is centered on the principals of equal opportunity for all employees. Consistent with our culture, all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, family status, marital status, sexual orientation, national origin, genetics, disability, age, or veteran status, or any other non-merit based or legally protected grounds. 
Visit our website and learn more about us at <a href="http://www.scientiavascular.com" target="_blank">www.scientiavascular.com</a>.

Clinical Affairs Manager

<h3>Job Description</h3>
Job DescriptionDescription:
SUMMARY:
The Clinical Site Manager (CSM) is essential in ensuring Elligo network sites are well-prepared to conduct clinical studies effectively and efficiently. Serving as the primary point of contact for new Elligo Traditional sites, the CSM provides comprehensive study management support across all sites or practices requiring trial assistance. Acting as a strategic partner, the CSM is accountable for each site's success, fostering a strong, collaborative relationship between Elligo and the site. By proactively identifying and addressing challenges, the CSM ensures an optimal and successful partnership and successful trial outcomes. This role demands exceptional client service skills and the ability to influence and guide senior stakeholders. It requires effectively managing through others, securing buy-in, and providing ongoing education to ensure seamless site support, successful study management, and adherence to all compliance and quality standards. In this role, the CSM is pivotal in strengthening Elligo’s network of sites, driving clinical trial efficiency, and ultimately contributing to the broader goal of advancing healthcare through effective clinical research.
 
ESSENTIAL DUTIES:
<ul>
<li>Build and maintain strong, long-term relationships with physicians, healthcare facility administrators, and key decision-makers within assigned practices</li>
<li>Strengthen Elligo’s presence by expanding relationships across key personnel, ensuring ongoing collaboration and trust.</li>
<li>Responsible for a portfolio of 10-12 clinical research sites; variable depending on business needs</li>
<li>Collaborate with Central Team CTLs, Clinical Site Managers, PIs, and practice-based study staff to ensure smooth study execution.</li>
<li>Coordinate communication between practices and internal teams to streamline processes and ensure alignment on goals.</li>
<li>Provide weekly site reports to your portfolio, including recruitment metrics, study performance and study pipeline. </li>
<li>Drive the growth and development of research programs by engaging new investigators and identifying additional therapeutic areas.</li>
<li>Collaborate with site staff to ensure recruitment goals are met or exceeded.</li>
<li>Provide site setup expertise, ensuring that new sites are qualified and prepared to conduct clinical trials efficiently.</li>
<li>Support the site staff in all trial-related activities, including audits and monitoring visits </li>
<li>Evaluate site equipment needs and work with internal teams to ensure the appropriate research infrastructure is in place.</li>
<li>Facilitate pre-study site qualification, study initiation, monitoring visits, and study closeout activities.</li>
<li>Assist with training and onboarding of new study staff and oversee new Clinical Research Coordinator (CRC) hires for up to six months to ensure competency.</li>
<li>Serve as the point of contact for study management activities, including feasibility and site qualification visits (PSVs), before a CRC is assigned.</li>
<li>Serve as the point contact for the site for site-related activities </li>
<li>Provide weekly and monthly performance reports to sites and practice leadership, including pipeline and financial reports. </li>
<li>Monitor the delivery of Elligo Powered By services, ensuring timely, accurate, and complete execution.</li>
<li>Manage documentation for all Elligo Powered By sites, including training, development, and adherence to Standard Operating Procedures (SOPs).</li>
<li>Work cross-functionally with other departments to ensure cohesive support for practices and the successful execution of clinical trials.</li>
<li>Collaborate with site staff and Elligo project leads to monitor and ensure the timely, accurate, and complete delivery of Elligo Powered By services.</li>
<li>Perform other duties as required or assigned. </li>
</ul>
 
SUPERVISORY RESPONSIBILITIES:
<ul>
<li>None</li>
</ul>
 
QUALIFICATIONS:
<ul>
<li>Excellent interpersonal skills and proven ability to build strong relationships and work with cross functional groups to effectively achieve business results. </li>
<li>Ability to work with functional groups and different levels of employees throughout Elligo to achieve business results effectively and professionally.</li>
<li>Proactive and timely follow-up skills, including the ability to organize applicable department timelines and follow up with internal and external stakeholder needs as needed.</li>
<li>Excellent verbal and written communication skills, including the ability to effectively convey ideas and information clearly, convincingly, and concisely. Additionally, clear and concise written and oral communication skills, including the ability to present ideas and suggestions clearly and effectively.</li>
<li>Strong organizational skills, including the ability to accomplish multiple tasks within the agreed-upon timeframes through effective prioritization of duties and functions in a fast-paced environment.</li>
<li>Proven track record of building and maintaining solid relationships with both internal and external stakeholders.</li>
<li>Self-motivated with the ability to work independently to complete tasks, respond to department requests, and collaborate with others to utilize their resources and knowledge to identify quality solutions with minimal direction from supervisor.</li>
<li>Skilled in interacting and collaborating with others, including peers, patients, management, and internal and external stakeholders</li>
<li>Strengths of character to working with doctors and being able to build relationships while also knowing when to push back and manage senior-level individuals. </li>
<li>Strong working knowledge of Good Clinical Practice guidelines and Federal research regulations.</li>
<li>Ability to comply with Elligo, Clinic, and Sponsor policies, Standard Operating Procedures (SOPs), GCP guidelines, and document data according to ALCOA. </li>
<li>High level of proficiency with clinical trial terminology and practices required</li>
<li>The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios, and achieve project timelines while being able to apply your understanding of study protocol(s).</li>
<li>Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS Office products such as Excel and Word.</li>
<li>Honest and ethical work approach to promote the development of life-changing treatments for patients.</li>
<li>Comply with Elligo, Clinic, and Sponsor policies, Standard Operating Procedures (SOPs), GCP guidelines, and document data according to ALCOA. </li>
</ul>
 
EDUCATION AND EXPERIENCE:
<ul>
<li>Bachelor’s degree (BA/BS) in Life Sciences or a related field or Associate degree with at least 4 years of experience in direct or indirect (such as clinical trials, RWE, life sciences, healthcare) CCRC/CCRP certification is preferred</li>
<li>Minimum of 3 years of experience in clinical research, preferably in a Clinical Research Coordinator role, with prior clinical research site management experience being ideal.</li>
<li>Experience managing budgets and contracts is preferred</li>
<li>Minimum of 3 years of experience in customer service</li>
<li>Minimum of 2 years of experience in client relationship management </li>
<li>Experience working with site networks is preferred</li>
<li>Previous experience with training and mentoring other clinical research professionals on the management of regulatory documents throughout the trial lifecycle is preferred.</li>
</ul>
 
ENVIRONMENT:
This is a remote position based on the location of the incumbent’s home and operating in a home-office environment. This role routinely uses standard office equipment such as computers, printers, copiers, and phones.
Occasional evening and weekend work may be required as job duties demand.
Approximately 30% of travel may be required to support the position’s responsibilities
 
PHYSICAL DEMANDS:
The physical requirements described here are representative of those that must be met by an employee to successfully perform the functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
While performing the duties of this job, the employee is required to:
<ul>
<li> Regularly work at a desk using a computer for prolonged periods.</li>
<li> Perform repetitive motion with substantial movements (motions) of the wrists, hands, and/or fingers.</li>
<li> Regularly communicate via e-mail, telephone, chat, and webcam (remote sessions such as MS Teams or Zoom), so others will understand and exchange accurate and timely information.</li>
<li> Frequently stand/walk, grasp objects, and perform light/fine manipulation of objects.</li>
<li> Occasionally move safely over uneven surfaces.</li>
<li> Occasionally reach/work above shoulders, twist/bend/stoop/squat, grasp forcefully, lift/carry/push/pull objects that weigh up to 20 pounds.</li>
</ul>
While performing the duties of this job, the employee is regularly required to sit, stand, walk, use hands and fingers to feel and handle, reach with arms and hands, talk and hear. While performing the duties of this job, the employee is frequently required to stoop, kneel, crouch, lift weights, or exert a force up to a maximum of 40 pounds.
 
ADDITIONAL:
Elligo Health Research is a dynamic organization in a rapidly changing industry. Accordingly, the responsibilities associated with this job may change from time to time in accordance with business needs. More specifically, the incumbent may be required to perform additional and/or different responsibilities from those set forth above.
The above declarations are not intended to be an all-inclusive list of the duties and responsibilities of the job described, nor are they intended to be such a listing of the skills and abilities required to do the job. Rather, they are designed only to describe the general nature of the job.
The incumbent must be flexible as there may be workweeks that require more than 40 hours to ensure the positions expectations and responsibilities are met. 
Elligo Health Research is committed to a policy of equal employment and will not discriminate against an applicant or associate based on his or her age, sex, sexual orientation, gender identity, race, color, creed, religion, national origin or ancestry, citizenship, marital status, familial status, physical or mental disability, handicap, military or veteran status, genetic information, pregnancy or any other category protected under federal, state or local law, regulation or ordinance.
Requirements:
Bachelor’s degree (BA/BS) in Life Sciences or a related field or Associate degree with at least 4 years of experience in direct or indirect (such as clinical trials, RWE, life sciences, healthcare) CCRC/CCRP certification is preferred
Minimum of 3 years of experience in clinical research, preferably in a Clinical Research Coordinator role, with prior clinical research site management experience being ideal.
Experience managing budgets and contracts is preferred
Minimum of 3 years of experience in customer service
Minimum of 2 years of experience in client relationship management 
Experience working with site networks is preferred
Previous experience with training and mentoring other clinical research professionals on the management of regulatory documents throughout the trial lifecycle is preferred.

Clinical Site Manager

<h3>Job Description</h3>
Job Description
The Clinical Project Manager will report to the Senior Director of Clinical Affairs and manage Clinical Research Associates as part of the Clinical Affairs Team. This remote position, available within 80 miles of a major U.S. airport, requires a highly organized individual with strong communication skills and attention to detail. The role involves leading clinical studies in compliance with Good Clinical Practice (GCP), local regulations, and company standards. Key responsibilities include managing clinical trial data, reviewing study documents, supporting clinical sites, and ensuring regulatory compliance. The position also involves vendor management, training site personnel, monitoring project timelines, and addressing study risks or issues. A bachelor's degree in a life sciences field and at least 3 years of experience in the medical device industry are required, along with knowledge of clinical regulations, excellent communication skills, and the ability to work independently. A Project Management Professional (PMP) certification is desirable. Travel up to 15% of the time is expected, and staying updated on scientific research is a key part of the role.
Key Responsibilities:
<ul>
<li>Clinical trial data management and support of sites.</li>
<li>Assist in the development of CRFs and other study related documents.</li>
<li>Independently review eCRFs and reports, ensuring that clinical trials are being conducted in accordance with protocols, GCP, ICH, SOP's and regulations (FDA/DEA).</li>
<li>Review and approve reports from site qualification visits, site monitoring visits and study close out visits. Provide support to the site staff in case of audits or inspections. Following up with clinical sites to ensure accuracy, integrity and completeness of the study data.</li>
<li>Managing regulatory documents and maintaining regulatory compliance, reviewing data entered into the EDC.</li>
<li>Oversee the contracting and management of vendors and ensure expectations are met.</li>
<li>Training of site personnel, identifying study related issues and escalating as needed.</li>
<li>Ensure the set up and maintenance of project plans are in compliance with company policies and timelines.</li>
<li>Identify, address and/or escalate study related risks, issues, mitigations, and opportunities for improvements.</li>
<li>Review and track clinical invoices.</li>
<li>Engage with Key Opinion Leaders (KOLs) in the fields of medicine or research.</li>
<li>Stay informed on the latest scientific research and clinical data relevant to Kuros Biosciences.</li>
<li>Ability to travel between 15% of the time.</li>
</ul>
Qualifications:
<ul>
<li>Bachelor's Degree in a life sciences field, (science related discipline preferred).</li>
<li>Minimum 3 years medical device industry experience. Experience in managing clinical trials whether by Sponsor and/or CRO, and on-site monitoring experience is required.</li>
<li>The highest ethical standards, specifically surrounding protected medical information and clinical research.</li>
<li>Working knowledge of relevant clinical regulations and industry standards including Good Clinical Research Practice, ICH, ISO, FDA and the MedTech EU Code of Practice.</li>
<li>Excellent verbal and written communication skills (protocols, reports, correspondence, etc.)</li>
<li>Proficiency in Word, Excel, PowerPoint, SharePoint, Microsoft Teams, etc.</li>
</ul>
Pay Range$100,000—$115,000 USD
About Us
Kuros Biosciences is on a mission to discover, develop and deliver innovative biologic technologies.
Our credentials
Kuros is a Swiss-headquartered biotech company, listed on the SIX Swiss Stock Exchange since 2016. With additional operations in the Netherlands and the USA, we continue to grow our global team. To deliver the ideal bone graft, you need the highest quality and quantity of scientific evidence behind it. We believe that this is a key differentiator for Kuros, given the urgent need to reduce fusion failures.
<ul>
<li>Listing on the SIX Swiss Exchange under the symbol KURN</li>
<li>A commercial &amp; research footprint that spans &gt;20 markets</li>
<li>4 teams of internationally renowned clinical and scientific expert advisers</li>
<li>&gt;25 orthobiologics-related patents</li>
<li>&gt;400 patients evaluated in Level I, randomized controlled clinical trials</li>
<li>10 well-controlled Level I-III clinical trials initiated, including 6 that are complete*</li>
</ul>
Today, nearly 1 in 5 spinal fusions fail. But what can we do to change this situation - for the benefit of patients, surgeons, and our wider society? This is the question that drives us at Kuros. Every day our team works across three continents to unlock the hidden secrets of bone healing through our research, development &amp; technology program: Project Fusion. To deliver the ideal bone graft, we believe you need the highest quality &amp; quantity of scientific evidence behind it. Which is why Project Fusion brings together an unprecedented blend of scientific, pre-clinical and clinical studies – all aimed at making the unpredictable…predictable.
Kuros Biosciences is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Kuros Biosciences complies with GDPR and the California Consumer Privacy Act (CCPA). View our CCPA Notice here.

<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:
 
The Manager, Clinical Application Specialist will oversee the execution of clinical applications and training programs to support the adoption and success of SpyGlass Pharma's ophthalmic drug delivery systems. This role involves managing a team of Clinical Application Specialists and ensuring that educational initiatives and clinical support meet the highest standards. The position requires collaboration with clinical sites, healthcare professionals, and internal stakeholders to drive patient and clinical outcomes while maintaining compliance with all regulatory and company standards.
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 team of Clinical Application Specialists to provide training and clinical support at investigative sites. </li>
<li>Develop and implement clinical application strategies to ensure successful deployment of SpyGlass Pharmas products in clinical and commercial settings. </li>
<li>Collaborate with the Clinical Research team to provide feedback and insights from clinical sites, contributing to the development and refinement of protocols and products. </li>
<li>Coordinate training programs for healthcare providers, ensuring proper understanding and application of product usage. </li>
<li>Maintain regular communication with clinical investigators and site staff to provide ongoing support and address challenges. </li>
<li>Track and evaluate the effectiveness of training and support activities, implementing improvements as necessary. </li>
<li>Ensure adherence to all FDA regulations, GCP guidelines, and company SOPs. </li>
<li>Represent SpyGlass Pharma at key industry meetings, conferences, and site visits. </li>
<li>Manage documentation and reporting for training and support activities to ensure consistency and compliance. </li>
<li>Support cross-functional teams, including Clinical Operations, Regulatory Affairs, and Quality Assurance, in achieving clinical objectives. </li>
</ul>
 
Qualifications Required for Position:
<ul>
<li>Bachelors degree in life sciences, healthcare, or a related field; advanced degree preferred.</li>
<li>10 years of experience in clinical applications or related roles within the pharmaceutical or medical device industry with at least 2 years in a supervisory or managerial role overseeing field-based CASs.</li>
<li>Proven experience managing a team in a clinical or technical support capacity.</li>
<li>Strong knowledge of GCP, FDA regulations, and clinical trial protocols.</li>
<li>Exceptional communication, training, and presentation skills.</li>
<li>Ability to work collaboratively with cross-functional teams and external partners.</li>
<li>Willingness to travel up to 40-60% domestically to support clinical sites and training programs.</li>
<li>Proficiency in Microsoft Office Suite and clinical data management systems. </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 Application Specialist, Manager

<h3>Job Description</h3>
Job DescriptionSalary: $62,000 - $77,000 
We are looking for an experienced Clinical Operations Manager I to join our team! 
 
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 is ideal for an individual who can motivate teams to do great work collaboratively in order to produce the best quality outcomes possible.
In this position you will:
<ul>
<li>Manage site identification and evaluation.</li>
<li>Develop or review essential study documents including protocols, case report forms (CRFs), source documents, project management plans, monitoring plans, reference tools, and study manuals.</li>
<li>Review site regulatory documents for compliance with CPC Standard Operating Procedures (SOPs) and applicable laws, regulations, and guidelines and to facilitate approval of investigational product release. </li>
<li>Prepare central IRB submissions and resolve IRB issues.</li>
<li>Manage site enrollment and study subject tracking and payments.</li>
<li>Assist with the monitoring of project deliverables and project timelines.</li>
<li>Develop and distribute project documents (e.g. safety reports, lab reports, deviations reports, monitoring reports, follow-up letters, meeting minutes, newsletters, and regulatory documents)</li>
<li>Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation.</li>
<li>Provide investigational product or device tracking and disposition as required by project.</li>
<li>Develop and manage site and vendor contracts including investigational product (IP) supply, interactive voice/web response system, electronic data capture system, core labs and other applicable clinical services. </li>
<li>Track and approve vendor payments.</li>
<li>Manage multidisciplinary project team members in relation to their role on assigned projects. Proactively identify issues and discuss resolutions with applicable department heads, project team, CPC executives and/or the sponsor. Track implementation of resolution through to completion and efficacy checks.</li>
<li>Ensure that the overall quality of project services and deliverables is maintained.</li>
<li>Provide status reports on all projects.</li>
<li>Participate in both onsite and offsite investigator meetings and training sessions.</li>
<li>Escalate budget, proposals and change orders discussions to Business Development.</li>
<li>Assist Business Development with benchmarking for budgets and development of sponsor proposals and service agreements.</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. Routinely advise management regarding the overall project status.</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>Schedule project team meetings and prepare meeting agendas and minutes as needed.</li>
<li>Perform other non-project related general administrative tasks such as filing, copying, faxing and shipping for assigned projects. </li>
<li>Cross-train within the project team, as needed. </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>Provide timely feedback on the progress of project assignments; help assess project issues and propose resolutions to the CPC project lead.</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>Manage the acquisition and supply of project specific materials to study sites.</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>
</ul>
Heres what you will need to bring to the table:
<ul>
<li>Nursing degree or BA/BS in a scientific field (or equivalent knowledge/experience)</li>
<li>3 years of experience in a clinical research setting (required) or 1 year of experience as a Research Assistant (required)</li>
<li>Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.</li>
<li>Experience with clinical site startup preferred.</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>Ability to interact with multiple individuals with varied skill sets in a positive, collaborative and educational manner.</li>
<li>Ability to adapt quickly to new situations, manage conflicts and resolve problems effectively.</li>
<li>Willingness to travel up to 25%.</li>
</ul>
Note:Viable applicants will be required to pass a background and education verification check.
 
Deadline to Apply: April 1, 2025
 
About 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 30 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:
 
<ul>
<li> Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)</li>
<li> Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)</li>
<li> 11 paid holidays</li>
<li>15 - 25 vacation days based on years of service</li>
<li>Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)</li>
<li> Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)</li>
<li> Flexible and remote work schedules</li>
</ul>
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>.
 remote work

Clinical Operations Manager I

<h3>Job Description</h3>
Job DescriptionCompany Description 
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at&nbsp;<a href="http://www.abbvie.com" target="_blank">www.abbvie.com</a>. Follow @abbvie on&nbsp;Twitter,&nbsp;Facebook,&nbsp;Instagram,&nbsp;YouTube&nbsp;and&nbsp;LinkedIn.&nbsp;
Job Description 
AbbVie Clinical Data Strategy and Operations is the best-in-class team within its cross-industry peer group. We are responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is a key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.&nbsp;&nbsp;&nbsp;
Responsibilities:
<ul>
<li>Develop a deep understanding of the capabilities and data flow for clinical technologies</li>
<li>Support the delivery of clinical technologies for a given program or therapeutic area</li>
<li>Track and analyze system timelines and metrics to ensure adherence to project plans, identify and mitigate potential risks and assess performance</li>
<li>Develop actionable reports and presentations for stakeholders and senior leadership to inform decision-making and project adjustments</li>
<li>Collaborate with internal and external stakeholders, including system leads, data management team, clinical teams and vendors</li>
<li>Contribute the strategic development of clinical technology initiatives and lead the implementation as the tech project manager</li>
<li>Maintain technical knowledge of the clinical data systems (EDC, IRT, eCOA, CDR and Imaging) and understand how the capability contributes to the submission data flow and overall DSS technology strategy</li>
<li>Mentor Clinical Data Strategy and Operations Associates</li>
<li>Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards</li>
<li>Act as the clinical data systems SME during regulatory inspections and internal quality audits</li>
</ul>
The preferred location for this role is AbbVie's Lake County, Illinois office on a hybrid onsite schedule; however, we are open to candidates working remotely within the United States.
Qualifications 
<ul>
<li>Bachelor’s degree in business, management information systems, computer science, life sciences, engineering or equivalent. Master’s preferred.</li>
<li>4+ years of pharmaceutical, clinical research, data management, health care technology experience or 6+ years of broader technology experience.</li>
<li>Familiar with clinical trial process and clinical technology.</li>
<li>Demonstrated knowledge of SAS and/or SQL programming skills and knowledge of database concepts.</li>
<li>Familiar with CDASH and SDTM Standards.</li>
<li>Demonstrated leadership traits and ability to influence without authority.</li>
<li>Demonstrated effective communication skills.</li>
<li>Demonstrated effective problem-solving and analytical skills.</li>
</ul>
 Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:&nbsp;​
​
<ul>
<li>
The compensation range described below is the range of possible base pay compensation that the Company believes in&nbsp;good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual&nbsp;compensation paid within this range will depend on many factors including geographic location, and we may ultimately&nbsp;pay more or less than the posted range. This range may be modified in the future.​
</li>
<li>
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision&nbsp;insurance and 401(k) to eligible employees.​
</li>
<li>
This job is eligible to participate in our short-term incentive programs.&nbsp;​
</li>
</ul>
​
Note: No amount of pay&nbsp;is considered to be&nbsp;wages or compensation until such amount is earned, vested, and determinable.&nbsp;The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits&nbsp;that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and&nbsp;may be modified at the Company’s sole and absolute discretion, consistent with applicable law.&nbsp;​
​
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.&nbsp;
US &amp; Puerto Rico only - to learn more, visit&nbsp;<a href="https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html" target="_blank">https://www.abbvie.com/join-us/equal-employment-opportunity-employer.ht…</a>
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
<a href="https://www.abbvie.com/join-us/reasonable-accommodations.html" target="_blank">https://www.abbvie.com/join-us/reasonable-accommodations.html</a>

199 Remote Clinical Trial Manager Jobs