<h3>Job Description</h3>
Company 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 <a href="http://www.abbvie.com" target="_blank">www.abbvie.com</a>. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 
Job Description
The Senior Manager, Clinical Data and Reporting Standards (CDARS) proactively participates in the development of data and reporting standards in support of AbbVie’s portfolio of clinical trials and ensuring AbbVie’s conformance to CDISC standards and industry best practices. This role implements the strategy and framework for governance of standards as set by the Head and Associate Directors of CDARS, and actively engages in deployment of next generation process and technology.
Standards Development responsibilities include:
<ul>
<li>Leading or participating in a cross-functional team of subject matter experts to define at least one of the following types of standards within the assigned therapeutic area:
<ul>
<li>Data Collection</li>
<li>Data Review Rules</li>
<li>SDTM mapping</li>
<li>ADaM mapping and derivation</li>
<li>Study-level tables, listings, or figures.</li>
<li>Product-level safety analysis displays</li>
</ul>
</li>
<li>Ensuring each standard is clearly defined, with appropriate documentation of relevant assumptions and decisions related to its use to support pipeline activities.</li>
<li>Support educating the organization on the proper use of standards in pipeline activities by contributing to the development of training materials.</li>
<li>Communicate ongoing standard development activities across the organization.</li>
</ul>
Pipeline responsibilities include:
<ul>
<li>Providing feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that support regulatory requirements to comply with CDISC standards (CDASH, SDTM and ADaM) and AbbVie standard extensions to CDISC.</li>
<li>Review and provide feedback on SDTM Trial Design Domains</li>
<li>Oversee the creation of SDTM define.xml, annotated CRF and Clinical Study Data Reviewer’s Guides for both FDA and PMDA submissions.</li>
<li>Consult on conformance issues for SDTM and/or ADaM and work with the study team to resolve the problem either by correcting the data or metadata, or by providing an appropriate explanation.</li>
</ul>
Other responsibilities include:
<ul>
<li>Representing AbbVie’s interests in industry standards development projects.</li>
<li>Staying current with industry standards such as CDISC, and the regulatory requirements related to their use.</li>
<li>Identifying improvements to the processes and content of standards and driving those improvements to completion.</li>
<li>May manage 3 or more direct reports.</li>
</ul>
This role can be based remotely anywhere within the U.S.
Qualifications
<ul>
<li>MS with 9 years of relevant clinical research experience, or BS with 11 years of relevant clinical research experience.</li>
<li>Experience leading development of standards for data collection, tabulation, analysis and/or reporting.</li>
<li>Experience with at least two of the following standards:  CDASH, SDTM, ADaM, Analysis Results Metadata, or TLF standards.</li>
<li>Active participation in CDISC teams preferred.</li>
<li>Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions.</li>
</ul>
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​
​
<ul>
<li>
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately 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 insurance and 401(k) to eligible employees.​
</li>
<li>
This job is eligible to participate in our short-term incentive programs. ​
</li>
<li>
This job is eligible to participate in our long-term incentive programs​
</li>
</ul>
​
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

Senior Manager, Clinical Data and Reporting Standards (Remote)

<h3>Job Description</h3>
Salary: $61,114 - $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>
  Here’s 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.

Targeted Compensation: $61,114 - $77,000

Deadline to Apply: June 1, 2024

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> 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 I

<h3>Job Description</h3>
BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Clinical Trials Associate to work for a leading Greater Los Angeles area biotechnology company. Pay Rate: $60-90/hour depending on experience This position will be REMOTE with occasional in-person meetings. All business related travel, hotel, and meals will be reimbursed. Summary:The Clinical Trials Associate with Oncology/Cell-Therapy experience will work in-house and will support the Manager, Clinical Operations in the conduct of clinical trials sponsored by the company. This individual will have responsibilities for aspects of the clinical trial to assist with study start-up, enrollment, maintenance, and close-out.
Responsibilities:
<ul>
<li>Support all operational aspects of assigned clinical trial(s), including conduct of study start-up, enrollment, study maintenance, and close-out.</li>
<li>Assist with the development, oversight, and/or completion of the clinical documents including, but not limited to:
<ul>
<li>Clinical study protocol</li>
<li>Informed consent form template (master and/or country-level) </li>
<li>Cell therapy product procedure manual and related forms</li>
<li>Clinical monitoring/management plan including report templates</li>
<li>Training slides and materials (e.g., SIV slides, protocol training materials)</li>
<li>Investigator Site File (ISF) structure and template documents</li>
<li>Others as needed study-specific documents, plans, charters, tools, trackers, etc. (including that of the CRO)</li>
</ul>
</li>
<li>Contributor and reviewer of the clinical documents below:
<ul>
<li>Clinical laboratory manual and requisition forms</li>
<li>CRFs and CRF completion guidelines</li>
<li>Interactive Response Technology (IRT) manual (e.g., IVRS, IWRS, IXRS)</li>
<li>Central imaging manual</li>
<li>Edit check / data review plan</li>
<li>Data review board charter (e.g., DSMB, SRC)</li>
<li>Safety management plan and SAE report form template</li>
</ul>
</li>
<li>Manage and/or support the Manager, Clinical Operations with oversight of the Trial Master File (TMF). Responsibilities include, but not limited to:
<ul>
<li>Filing clinical documents in the Trial Master File (TMF)</li>
<li>Assisting with the development, oversight, and/or completion of the TMF index and TMF management plan.</li>
<li>Periodically reviewing the TMF for reconciliation and QC, following up with the clinical sites, clinical trial monitors, and/or vendors to close-out TMF-related issues.</li>
</ul>
</li>
<li>Support the Manager, Clinical Operations with various meetings, may include assisting in developing meeting agendas, writing meeting minutes, and facilitating review of minutes:
<ul>
<li>Internal study team meeting</li>
<li>Other internal clinical operations meetings</li>
<li>Working group meetings</li>
<li>CRO/vendor meetings</li>
</ul>
</li>
<li>Support the Manager, Clinical Operations in the selection process of vendors and/or contractors supporting a study, including but not limited to:
<ul>
<li>CRO</li>
<li>Clinical trial monitors</li>
<li>Central lab</li>
<li>Central imaging</li>
<li>EDC system</li>
<li>IRT system</li>
</ul>
</li>
<li>Support the Manager, Clinical Operations in overseeing, managing, and tracking performance of assigned vendors selected for a clinical study which could include acting as a point of contact as delegated by the manager, facilitating review of vendor study specific documents, tracking performance indicators for vendors, creating and maintaining a vendor-specific issues log.</li>
<li>Ensures documentation of training for internal study team, vendors, third party contractors, and sites.</li>
<li>Help manage, oversee, and track performance of clinical sites selected for a clinical study, which could include acting a point of contact for the sites.</li>
<li>Facilitate sponsor review and approval of site-specific documents (e.g., site-specific ICF, patient facing materials, etc.).</li>
<li>Proactively identifies potential study issues/risks and recommends/implements solutions.</li>
<li>Participate in the development, review and implementation of departmental SOPs and processes.</li>
<li>Contribute to the selection of contractors or FTEs that join the company</li>
<li>Other duties as assigned. </li>
</ul>
Qualifications:
<ul>
<li>Minimum requirement of a BA/BS or equivalent degree, plus 1-2 years of direct experience in clinical operations supporting clinical drug development within the oncology and/or cell therapy space; OR minimum 3 years of direct experience in clinical operations supporting clinical drug development with no experience in oncology and/or cell therapy clinical studies.</li>
<li>Experience and/or knowledge of transplant patient care and apheresis collection for clinical trials strongly preferred.</li>
<li>Experience participating in the selecting and managing of CROs and other clinical trial vendors (e.g., central lab, central imaging, etc.)</li>
<li>Knowledge and understanding of ICH guidelines, GxPs for conduct of clinical trials, and FDA and EMA regulations.</li>
<li>Outstanding organizational skills with the ability to multi-task and prioritize.</li>
</ul>
Please send resumes to <a href="mailto:tiffany@biophaseinc.com" target="_blank">tiffany@biophaseinc.com</a> and visit our website at <a href="http://www.biophaseinc.com" target="_blank">www.biophaseinc.com</a> for additional job opportunities!!!

Clinical Trials Associate (REMOTE)

<h3>Job Description</h3>
Job Description
Position Overview:
This is a full-time position with the ability to work remotely.
Eastern time zone (EST) and access to transportation to the Northeastern United States for periodic team meetings or other obligations preferred.
Reporting to Project Management Leadership, the Project Manager is a highly organized, self-motivated, and experienced individual who supports global project management activities for clinical research studies. The right candidate will direct communications with study team members and collaborators to ensure study milestones and project expectations are met.  This is a highly collaborative role, and this position is expected to develop and maintain strong relationships with multiple study stakeholders, including study cores, vendors, and study sponsors. This role provides a great opportunity to join a flexible dynamic company that is growing with value placed on career growth, as well as the opportunity to be part of a team of creative minded people.
About Mitro:
MITRO Biotech Co., Ltd. is a global molecular imaging contract research organization (MI-CRO) company with its headquarters located in China. MITRO provides outstanding contract research for new drug development using radiolabeling and molecular imaging techniques. MITRO offers integrated solutions, including evaluation of potential therapeutics, biodistribution, pharmacokinetics and pharmacodynamics as well as translational research using a wide range of non-clinical through Phase 0 clinical trial services. MITRO’s focus includes but is not limited to: cancer, coronary heart disease, Alzheimer disease, epilepsy, Parkinson disease, rheumatoid arthritis, diabetes, gene expression, and stem cell research.
MITRO Biotech Co., Ltd.’s acquisition of XingImaging, LLC in September 2023 brought with it an active expansion to offer early through late phase PET clinical imaging and clinical services to industry sponsors and researchers for advancement of new imaging tracers for evaluation of diagnostic indicators, disease progression, and therapeutic medicines.
Key Responsibilities:
· Track and report on the progress of assigned studies including budget and timelines. Manage large and/or complex studies and projects.
· Answer or triage complex study or operational questions and troubleshoot study issues as they arise.
· Serve as a trusted team leader providing operational oversight of company contracted study activities, with a focus on study metrics compiled across projects and regularly shared with leadership. Collaborate closely with cross-functional teams by applying experience and expertise with the joint goal of developing or furthering company policies and processes.
· Cultivate strong relationships across clinical study ecosystem, including but not limited to study leadership, study core staff, external vendors and collaborators, and study sponsors.
· Contribute to project planning and operations, working to exchange information, solve problems, resolve conflicts, and develop workflow processes.
· Serve as the key manager of project meetings, including scheduling meetings, developing agendas and meeting materials, coordinating meeting/call speakers, circulating meeting minutes, and proactively tracking status of action items through completion.
· Function as forward-facing contact for all assigned project communications.
· Collaborate with finance team to ensure proper tracking, invoicing and reconciliation of project budgets and timelines.
· Aptitude to conduct trainings and identify project management-related training needs.
· Support structural growth of XingImaging as an evolving company through procedure creation and process improvement.
Qualifications and Requirements:  
•   Undergraduate college degree, preferably in relevant field for application to role
•   Strong background in program/project management with excellent organization, communication and leadership skills
•   A strong understanding of GDocP, GCP and other regulatory requirements for clinical trials.
•    Experience working within the clinical research field, with at least 2 years’ experience performing project management for complex initiatives.
•    Demonstrated problem-solving and critical thinking skills, as well as ability to develop processes where there is no existing roadmap.
•    Must be a self-starter able to excel independently; this is a remote position and success will be measured by timeliness of deliverables and reaching milestones.
•    Excellent time-management skills; ability to prioritize work at hand and manage multiple tasks to accomplish timelines.
•    Strong interpersonal and people management skills; ability to work productively both independently and as part of a team, and the ability to cultivate strong relationships with individuals of varied backgrounds.
•   Demonstrated experience with a fast-paced team environment; comfort with ambiguity and flexible about changing dynamics and priorities.
•    Ability to independently manage more than one activity with minimal oversight.
Preferred:
•    Willingness and access to transportation to the Northeastern United States for periodic team meetings or other obligations.
•    Eastern Standard time zone preferred.
•    Experience engaging with diverse research stakeholders including regulatory bodies, research vendors/collaborators, and others in a clinical research setting(s).
• Understanding of neurodegenerative disorders.
What We Offer:
·  Competitive Salary
·  Comprehensive Health Insurance Plan
·  Long-Term Disability
·  Life Insurance
·  Retirement Plan
MITRO provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability,  genetic information,  service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Equal employment opportunity applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfer, leave of absence, compensation, and training.
To apply for this position please send a cover letter and CV/resume to Lindsay Hubbell, Human Resources, at <a href="mailto:lhubbell@xingimaging.com" target="_blank">lhubbell@xingimaging.com</a>
Company DescriptionMITRO Biotech Co., Ltd. is a molecular imaging contract research organization (MI-CRO) company in China. MITRO provides outstanding contract research for new drug development using radiolabeling and molecular imaging techniques. MITRO provides integrated solutions, including evaluation of potential therapeutics, biodistribution, pharmacokinetics and pharmacodynamics. MITRO provides translational research using a wide range of non-clinical through Phase 0 clinical trial services. MITRO’s focus includes but is not limited to: cancer, coronary heart disease, Alzheimer disease, epilepsy, Parkinson disease, rheumatoid arthritis, diabetes, gene expression, and stem cell research. MITRO Biotech Co., Ltd.’s acquisition of XingImaging, LLC in September 2023 brought with it an active expansion to offer early through late phase PET clinical imaging and clinical services to industry sponsors and researchers for advancement of new imaging tracers for evaluation of diagnostic indicators, disease progression, and therapeutic medicines. 
<h3>Company Description</h3>
MITRO Biotech Co., Ltd. is a molecular imaging contract research organization (MI-CRO) company in China. MITRO provides outstanding contract research for new drug development using radiolabeling and molecular imaging techniques. MITRO provides integrated solutions, including evaluation of potential therapeutics, biodistribution, pharmacokinetics and pharmacodynamics. MITRO provides translational research using a wide range of non-clinical through Phase 0 clinical trial services. MITRO’s focus includes but is not limited to: cancer, coronary heart disease, Alzheimer disease, epilepsy, Parkinson disease, rheumatoid arthritis, diabetes, gene expression, and stem cell research.\r\nMITRO Biotech Co., Ltd.’s acquisition of XingImaging, LLC in September 2023 brought with it an active expansion to offer early through late phase PET clinical imaging and clinical services to industry sponsors and researchers for advancement of new imaging tracers for evaluation of diagnostic indicators, disease progression, and therapeutic medicines.

Clinical Research Project Manager

<h3>Job Description</h3>
Experic is an industry-leading contract development and manufacturing organization (CDMO) and clinical trial supply services company. Our vision is to deliver innovative and scalable solutions for every phase of a product's life cycle from clinical to commercial. We offer advanced pharmaceutical manufacturing, packaging, and labeling technologies that can accommodate a variety of dosing and packaging formats. We take pride in our precision capabilities, state-of-the-art filling equipment, advanced technologies, and Class A regulatory compliant cGMP facilities. Our main goal is to provide our clients personalized attention and ensure the smooth and successful completion of their pharmaceutical development programs. 

We aspire to develop a team culture based on trust, integrity, ethical behavior, and compliance, with a relentless focus on delivering high quality results. If you value a collaborative work environment and are energized by the opportunity to truly make a difference, come and Experience the Experic difference. We believe in fostering a fair and respectful work environment that encourages open communication and continuous improvement. At Experic, you can experience a fulfilling career, do meaningful work, and grow professionally and personally. A successful candidate will bring their unique thinking, expertise, and approach while sharing our core values.

This position is remote OR based in our Cranbury NJ office with flexibility to work from home 2 days/week. The successful candidate will be responsible for the project management of assigned clients including but not limited to the planning of project resources, assembling, or leading the project team, time management, budget, scope, quality and satisfaction, risk management, monitoring progress, documentation, and reporting.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
<ul>
<li>Management of project related activities from definition to launch stage to ensure that projects are delivered on-time, within approved budget and achieves project objectives.</li>
<li>Organize and lead project core team meetings.</li>
<li>Maintains effective communication and working relationships among project core team.</li>
<li>Ability to translate clinical trial synopsis / clinical trial protocol into an efficient and cost-effective plan including, but not limited to:</li>
<li>Material Management</li>
<li>Manufacturing, Packaging &amp; Labeling - Prepare documents such as, but not limited to, material specifications and batch records.</li>
<li>Prepare required distribution documentation, enter &amp; monitor shipments</li>
<li>Prepare required Returns, Accountability and Destruction documentation.</li>
<li>Manage all project related inventory to avoid stock out scenarios</li>
<li>Work with cross-functional team members to assess feasibility of project scope and objectives and develop detailed project timeline to ensure that there is enough flexibility and contingency in the plan to respond to unanticipated difficulties.</li>
<li>Define and assign schedules and track cross-functional tasks/activities to ensure that project progress within expected timings.</li>
<li>Management of monthly project invoicing.</li>
<li>Identify, monitor, communicate and resolve issues, scope changes, budget variances or other project objective hurdles that may arise during the project execution.</li>
<li>Interface with all functional areas of the business to ensure timely, effective, and efficient execution of project tasks.</li>
</ul>

ADDITIONAL POSITION REQUIREMENTS
<ul>
<li>Lead risk analysis &amp; mitigation planning for projects.</li>
<li>Prepare and present project progress reports and presentations as required.</li>
<li>Carries out duties in compliance with all federal and state regulations and guidelines.</li>
<li>Complies with all company and site policies and procedures including but not limited to safety, standard operating procedures, and work instructions.</li>
<li>Remains current in profession and industry trends.</li>
<li>Makes a positive contribution as demonstrated by:</li>
<li>making suggestions for improvement</li>
<li>learning new skills, procedures, and processes.</li>
<li>Is available for other duties as required.</li>
</ul>
QUALIFICATIONS: EDUCATION and/or EXPERIENCE
Bachelor's Degree preferred and three (3) years of project management experience in packaging, labeling and clinical supply chain as Project Manager or Project Coordinator; or six (6) years of project management experience in packaging, labeling and clinical supply chain as a Project Manager or Project Coordinator. Commercial packaging experience a plus.
LANGUAGE SKILLS
<ul>
<li>Read and interpret documents such as standard operating procedures, manuals, batch records, work instructions and specifications.</li>
<li>Legible Handwriting</li>
<li>Communicate clearly in writing and orally.</li>
</ul>

OTHER SKILLS, ABILITIES OR QUALIFICATIONS
<ul>
<li>Demonstrate practical knowledge of 21 CFR 210, 21 CFR 211, 21 CFR Part 11, Eudralex Volume 4 and Annex 13.</li>
<li>Demonstrate effective collaboration and teamwork.</li>
<li>Demonstrate experience managing contract pharmaceutical projects on time and on budget.</li>
<li>Demonstrate experience working in a cGxP environment.</li>
<li>Familiar with project management tools and technologies such as Microsoft Project.</li>
<li>Knowledge of various project management methodologies.</li>
<li>Successfully completes regulatory and job training requirements.</li>
<li>Computer skills:</li>
<li>Enter data into computer using software applications for data entry and word processing.</li>
<li>Work and be proficient with e-mail systems.</li>
<li>Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.</li>
<li>Ability to work with others in a team environment.</li>
</ul>

TRAVEL
<ul>
<li>Domestic travel will be required less than 5% of the time.
EXPERIC is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
</li>
</ul>

Clinical Supply Project Manager - Remote or Hybrid/Cranbury NJ

<h3>Job Description</h3>
Salary: $140,000 - $150,000 / yearly
Title: Senior Manager, Clinical Operations

Overtime Status: Exempt

Employment Status: Full-Time

Pay Range: $140,000 - $150,000 /yearly DOE

The hiring pay range for this position is $140,000 - $150,000 per year based on skills, education, and experience relevant to this role.

Inventprise is a mission-driven bio-pharmaceutical company addressing global health inequalities by empowering people to live healthy lives. We do this by developing novel vaccines targeting infectious diseases for which there are no current preventive interventions or by optimizing currently marketed vaccines to provide a broader spectrum of protection, making them cheaper and more stable than before. We aspire to provide breakthrough public health interventions for all populations, globally. Inventprise is led by pioneers in vaccine discovery, seasoned experts in manufacturing and vaccine development, and proven commercialization veterans.  

At Inventprise, we believe our people are our most valuable asset. We are strongly committed to a range of workplace programs that support the well-being, growth, and engagement of our employees and our business. What we offer:

Benefits:
Effective the first of the month following the date of hire, employees are eligible to participate in the following Inventprise employee benefit programs:

<ul>
<li>Medical, Dental, Vision, FSA, or HSA:  Currently Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and enrolled spouse and dependents.  Medical plans are currently provided through Premera Blue Cross.</li>
<li>401(k) program: Inventprise contributes 3% of employee base pay each pay period to their 401(k) account. Employee contributions are at the discretion of the employee.</li>
<li>Paid Time Off: Employees start PTO accruals at the rate of 5.83 hours each pay period - annualized equivalent of 140 hours/year.</li>
<li>Paid Holidays: Inventprise offers 9 paid holidays each year: New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, Day after Thanksgiving Day, Christmas Day, and two floating holidays. </li>
<li>Stock &amp; Bonus Plans: Employees are eligible to participate in the Company’s Bonus and Stock Award Plans.</li>
</ul>

Summary: 
This role will be responsible for independently providing operational oversight of the planning, implementation, and close-out of vaccine clinical trials sponsored by Inventprise Inc. In collaboration with Portfolio Management, the role will also interface with the various internal and external stakeholders in the area of clinical supplies, clinical testing management, vendor management and other cross-functional teams.

Duties And Responsibilities:
<ul>
<li>Develop, maintain, and manage high-quality detailed study timelines; interface regularly with study team and internal cross-functional stakeholders to ensure key activities are well-coordinated, are accurately reflected on the study- and program timelines and align with corporate and program goals.</li>
<li>Prospectively identify timeline risks, proactively communicate risks to management, internal stakeholders, and CRO teams, and coordinate development and implementation of risk mitigation strategies to facilitate efficient, on-time execution of studies.</li>
<li>Collaborate with other functional groups within the company where necessary to support milestone achievement.</li>
<li>Manage routine status reporting including study timeline and budget dashboards and management updates.</li>
<li>Provide monthly milestone and timeline updates to Portfolio Management for entry into corporate project management system.</li>
<li>Develop, maintain, and manage high-quality detailed study timelines; interface regularly with study team and internal cross-functional stakeholders to ensure key activities are well-coordinated, are accurately reflected on the study- and program timelines and align with corporate and program goals.</li>
<li>Prospectively identify timeline risks, proactively communicate risks to management, internal stakeholders, and CRO teams, and coordinate development and implementation of risk mitigation strategies to facilitate efficient, on-time execution of studies.</li>
<li>Coordinate development and review of IP labels, working closely with relevant functional areas to produce a final mockup label meeting clinical and regulatory requirement.</li>
<li>Develop and contribute to appropriate study plans (e.g., monitoring, pharmacy, data management, laboratory, manual of procedures, communication, etc.).</li>
<li>Oversee protocol implementation by reviewing progress reports from CROs, monitoring, and data quality reports, and audit reports as needed.</li>
<li>Support procurement, import, and delivery of clinical trial supplies (including Investigational Product) according to trial protocol specifications.</li>
<li>Oversee clinical trial registry postings.</li>
<li>Provide input into the selection and qualification of clinical trial sites and CROs</li>
<li>Provide input into the contractual activities of clinical sites and CROs, including outlining partner roles and responsibilities and technical milestones triggering payments.</li>
<li>May work on 1-3 clinical studies depending on complexity and design</li>
</ul>

Education and Experience:
<ul>
<li> Bachelor’s in related discipline required; a combination of relevant education and applicable job experience may be considered.</li>
<li>7 years of related experience in a CRO, Biotech or Pharmaceutical organization</li>
<li>Solid understanding of drug development and clinical operations.</li>
<li>Excellent organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.</li>
<li>Excellent computer skills including advanced knowledge in MS Excel, Word, PowerPoint and Outlook.</li>
<li>Must be a self-starter who works with minimal supervision.</li>
<li>Works effectively in a matrix cross-functional environment.</li>
<li>Good business judgment and a strong understanding of the unique aspects of clinical financials.</li>
<li>Excellent communication skills, (verbal and written) including the ability to understand and present budget information effectively.</li>
<li>Works with high sense of accountability/urgency</li>
<li>Expertise in GCP, ICH, and other Guidance documents and policies related to clinical trial operations.</li>
</ul>

Physical Demands:
<ul>
<li>Adequate visual and mental acuity to maintain prolonged use of computer work.</li>
<li>Multiple hours of standing, sitting, or walking when performing computer work.</li>
</ul>

Mental Demands:
<ul>
<li>Requires operational discipline to consistently focus and execute work-related tasks, with a minimum of human error. This involves self-checking of work immediately upon completion, the ability to find / correct errors (with oversight by the Supervisor).</li>
<li>Self-directing, once training is successfully completed, but with need to immediately elevate potential concerns/discrepancies to management in a timely fashion.</li>
<li>Must maintain a professional demeanor in communicating with all Inventprise personnel.
</li>
</ul>
Working Conditions:
<ul>
<li>Remote, with on-site presence based on business needs. , </li>
<li>International and domestic travel 15-20%.</li>
<li>Must have expertise in MS Project/Smartsheet.</li>
</ul>

Inventprise is an equal-opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender, identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.
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Senior Manager, Clinical Operations

<h3>Job Description</h3>
POSITION TITLE: Clinical Project Manager
DEPARTMENT: Posterior Segment
Ora Values the Daily Practice of …
Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor
At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects.Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.
The Role:
Ora's Clinical Project Managers (CPM) are critical in driving clinical ophthalmic projects forward utilizing best practices in order to ensure budgets, timelines, and clinical trial requirements are being met on behalf of the sponsor. This role will work independently to manage cross functional project teams. CPM's have active involvement in each assigned project in order to meet milestones, resolve issues and/ or conflicts in addition to frequent interactions with the study team including but not limited to clinical trial associates, monitoring, clinical research coordinators, investigators and senior management. They are responsible for creating project plans and provide weekly budget and progress reviews for each study in addition to preparing high-quality reports.
What You'll Do:
<ul>
<li>Manages cross functional project teams derived from the groups within clinical development to deliver a high-quality clinical trial(s) in compliance with all regulations and SOPs.</li>
<li>Works with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial projects. The CPM acts as an operational nexus or focal point for interdepartmental and intradepartmental groups (e.g. stats, data management, safety, manufacturing, regulatory, vendors), coordinating these different groups in a matrix environment to drive and complete clinical programs.</li>
<li>Reviews protocol, source documents and CRFs and tracks them to completion.</li>
<li>Responsible for creating and maintaining project timelines for each project and uses these timelines to track and manage a project's progress.</li>
<li>Responsible for creating Project Plans (Roles and Responsibility Tables and Communication Plans) and weekly project budget and progress reviews for each study.</li>
<li>Reviews study metrics for performance and quality with the team and management.</li>
<li>Prepares high-quality reports (financial, project, etc.) for management on program status and issues.</li>
<li>Ensures review of clinical electronic Trial Master File (eTMF) for completeness.</li>
<li>Manages and coordinates all vendors involved in the clinical trials (e.g. central labs, IVRS, reading centers).</li>
<li>May represent Ora at professional meetings or seminars.</li>
<li>Participates in preparing new study budgets, proposal documents and participating in bid defenses.</li>
<li>Active role in department and company-wide process improvement initiatives.</li>
<li>Travel of up to 15% is required (mainly domestic, overnight).</li>
<li>Adhere to all aspects of Ora's quality system.</li>
<li>Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity &amp; business ethics and regulatory requirements.</li>
<li>Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.</li>
<li>Responsibilities may differ from the above based on the specific needs of the business.</li>
</ul>
What We Look For: 
<ul>
<li>Experience needed for the Role: 
<ul>
<li>Bachelor's degree in Life Science with at least 5 years of clinical trial experience. Years of experience may be considered in lieu or education.</li>
<li>Minimum of 1 year of clinical project management experience</li>
</ul>
</li>
<li>Additional Skills &amp; Attributes:
<ul>
<li>Ophthalmology experience preferred.
<ul>
<li>Understanding of multi-center drug and/or device trials.</li>
<li>Experience with Veeva TMF and CTMS systems.</li>
</ul>
</li>
</ul>
</li>
<li>Competencies and Personal Traits:
<ul>
<li>What We Do:
<ul>
<li>Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.</li>
</ul>
</li>
<li>How We Do It:
<ul>
<li>IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.</li>
<li>Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.</li>
</ul>
</li>
<li>Why We Do It:
<ul>
<li>Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.</li>
</ul>
</li>
</ul>
</li>
</ul>
What We Offer:
<ul>
<li>Well Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.</li>
<li>Flexible PTO &amp; Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays. </li>
<li>Financial: Competitive salaries along with a 401K plan through Fidelity with company match.</li>
<li>Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave.</li>
<li>Company Paid Life &amp; Disability Insurance: Offering peace of mind to help you and your family feel secure.</li>
<li>Remote &amp; Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases.</li>
<li>Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family.</li>
<li>Career Development Opportunities:Continued opportunities to grow and develop your career journey. </li>
<li>Global Team: Opportunities to work with colleagues across the globe.</li>
<li>Impact: A chance to research new ophthalmic therapies that will impact patients across the globe.</li>
</ul>
Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.
Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.
We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Our Privacy Policy | Ora (oraclinical.com)

Clinical Project Manager

<h3>Job Description</h3>
SiteBridge Research, Inc:
Founded in 2021, SiteBridge Research is an integrated research organization, focused on building a national network of small and community medical practices to deliver world-class industry sponsored clinical research studies on time and on budget, accelerating time to completing clinical trials, accelerating time to market and product adoption in communities that are often underrepresented and difficult to reach. The SiteBridge Network extends reach further into these communities to empower patients with some of the highest unmet needs to take part in clinical studies to improve inclusivity in clinical research and to improve overall health outcomes.
Job Description: The Clinical Research Project Manager is an experienced research professional who will provide support and manage projects with, and under the direction of, the Director of Clinical Research Coordinators &amp; Project Managers for multiple ongoing studies within our site network. This role requires in-depth industry understanding, knowledge, experience, and flexibility to make informed and effective decisions independently. The Clinical Research Project Manager will be responsible for identifying, developing, and gathering the necessary resources to complete clinical research projects and coordinate the project’s start-up, maintenance, and close-out activities. They will be required to work closely with the site staff to ensure the deliverables and timelines are met. In addition, and most importantly, this role represents SiteBridge Research’s mission and vision by focusing on the trusted physician/patient partnership from start to finish for every clinical trial conducted at the site and is key in transforming clinical research for every participant. The position will maintain the operational excellence required of clinical sites/staff involved in clinical studies and ensure ICH/GCP and SOP compliance. This role will report to the Director of Clinical Research Coordinators &amp; Project Managers and the Head of Clinical Operations. This position is remote with up to 40% travel for candidates with the prerequisite experience.
Responsibilities: 
<ul>
<li>Work closely under the direction of the Director of Clinical Research Coordinators &amp; Project Managers to coordinate project start-up, maintenance, and close-out activities (including but not limited to study start-up and close out, recruitment, and regulatory submissions) </li>
<li>Work collaboratively with the Clinical Operations leads, Project Managers, and site team to ensure project deliverables are completed.</li>
<li>As necessary, step in and fill site and study level needs (including but not limited to site set-up and CRC duties to meet SBR and sponsor needs)</li>
<li>Ensure ongoing communication to team members of the scope of work, timeline and project goals, technical information, and input from study teams throughout the project, including significant changes in resourcing, scope of work, and timelines</li>
<li>Evaluate and communicate metrics of all activity related to assigned projects </li>
<li>Consult with SiteBridge Leads to determine the best course of action for projects related to the site and trials </li>
<li>Effectively communicate with physicians, sponsors, stakeholders, and study staff as related to assigned projects</li>
<li>Track study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policies </li>
<li>Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, and communicating to the team in an open, balanced, and objective manner</li>
<li>Prepare, participate in, and follow-up on audits/inspections as needed</li>
<li>Participate in required training and education programs.</li>
<li>Participate in meetings (i.e., Investigator Meetings, Site Trainings, Conferences) and seminars to update knowledge of clinical research and related issues as necessary </li>
<li>Other duties and support as assigned related to site and study operations</li>
<li>Travel is required (up to 40%) for projects related to site development and operations</li>
</ul>
Qualifications/Required Experience: 
<ul>
<li>Minimum Bachelor's degree; a combination of education and related technical/professional experience may be substituted for the degree requirement and will be considered on a case-by-case basis</li>
<li>Minimum of 4 years of clinical research or related experience; experience as CRC, CRA, or related is required</li>
<li>Minimum of 2 years of Project Management experience highly preferred </li>
<li>Bilingual, Spanish speaking candidates are encouraged to apply</li>
<li>Proven success managing and integrating multiple projects across an organization</li>
<li>Demonstrated knowledge of clinical trials project management and execution related to but not limited to start-up, regulatory submission, site feasibility, etc.</li>
<li>Excellent working knowledge of FDA &amp; ICH GCP regulations and guidelines is required </li>
<li>Experience with eSource, eRegulatory, and CTMS is required</li>
<li>Experience in study document preparation (CRF, eSource, logs, SOPs, etc.) is a plus</li>
<li>Strong preference for experience within multiple phase research and therapeutic areas</li>
<li>Experience with necessary clinical study and staff records related to clinical study activity which includes case report forms, drug dispensation records, etc. </li>
<li>Excellent communication skills, attention to detail, problem-solving, follow through, and organizational skills, with the ability to multi-task and work under/meet deadlines </li>
<li>Detail-oriented and meticulous in all aspects of work </li>
<li>Superior interpersonal, organization, and management skills</li>
<li>Capable of working independently with minimal supervision</li>
<li>Understanding of medical terminology as well as standard clinical procedures and protocols </li>
</ul>
Additional Qualifications: 
<ul>
<li>Strong project and time management skills </li>
<li>High level of collaboration; customer-oriented awareness and focus </li>
<li>Skilled with standard computer programs including the MS Office suite </li>
<li>Strong interpersonal and written and verbal communication skills </li>
</ul>
Additional Information:
SiteBridge Research, Inc. is proud to be an Equal Opportunity Employer providing employees with a work environment free of discrimination and harassment. We respect and seek to empower each individual and value the diverse cultures, perspectives, skills, and experiences within our workforce. We celebrate diversity and do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability status, or any other applicable characteristics protected by law. All employment decisions at SiteBridge are based on business needs, job requirements and individual qualifications and performance.

<h3>Job Description</h3>
Salary: $72,000 - $90,000
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>
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, 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>
</ul>
<ul>
<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>
</ul>
<ul>
<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 - $90,000 annually
Deadline to Apply: June 1, 2024
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> 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>.
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57 Remote Clinical Trial Manager Jobs