Clinical Trials Project Manager II
3 weeks ago
We are seeking a highly skilled Clinical Trials Project Manager II to oversee clinical operations management activities and ensure the successful execution of clinical trials.
Key Responsibilities:
- Define and monitor project scope, timelines, and deliverables from project initiation to close-out.
- Oversee trial-related activities, including vendor management and data management.
- Provide expert advice in the design, writing, and review of project-related essential documents.
- Develop and manage multidisciplinary project teams, ensuring effective communication and collaboration.
- Ensure the overall quality of project services and deliverables, adhering to local, federal, and international regulations.
- Work closely with the Business Development team to plan and execute investigator meetings and manage budgets, proposals, and change orders.
- Collaborate with the Head of Trial Master File to establish and maintain Trial Master Files (TMFs) and project document files.
Requirements:
- Nursing or BA/BS in a scientific field (or equivalent knowledge/experience).
- 4 years of experience in a clinical research setting, including a minimum of 2 years of project/operations management experience in clinical research.
- Demonstrated ability to manage all facets of a clinical trial with minimal direction.
- Thorough knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations.
- Proficiency in Microsoft Office, particularly Outlook, Word, and Excel.
- Excellent communication and organizational skills.
- Ability to adapt quickly to new situations, manage conflicts, and resolve problems effectively.
About CPC:
CPC is an academic research organization offering full-service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in various therapeutic areas.
We have over 30 years of experience, providing services to over 150 clinical trials in various indications, with an emphasis on cardiovascular, wound healing, diabetes, and more.
CPC has expertise in managing clinical trials from various funding sources, including Industry, NIH, and Investigator Initiated trials.
We offer a comprehensive benefits package, matching 401(k) plan, 11 paid holidays, 15-25 vacation days, paid sick time, and flexible work schedules.
CPC provides equal employment opportunities to all employees and applicants for employment without regard to race, 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.
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