Senior Project Manager
1 week ago
Job Summary:
Cpl Life Sciences is seeking a highly experienced Senior Clinical Project Manager to join our team. As a key member of our clinical operations team, you will be responsible for supporting the delivery of clinical studies, ensuring quality and compliance.
Key Responsibilities:
- Support the delivery of clinical studies, ensuring quality and compliance.
- Responsible for clinical operations planning, oversight, and execution of a clinical trial, including overall timelines, budget, and key deliverables.
- Manage the operational execution of a clinical trial, inclusive of all aspects of study conduct.
- Participate on the clinical operations team and work closely with the medical team and other functional areas in support of the clinical strategy and development plan.
- Coordinate the day-to-day activities on a clinical trial, both within the company and through a wide variety of CROs and vendors.
- Provide clinical operations oversight and direction to both internal functional groups and external CROs/vendors to ensure trial goals and objectives are met on time and on budget.
- Lead activities in the assessment and selection of CROs/vendors and participate in budget and contract negotiations.
- Provide input and oversight in the development of clinical plans, protocols, SAPs, consent forms, and other study-related documents.
- Provide input into, track, analyze, and report performance metrics for each clinical trial.
- Provide leadership/guidance to the study execution team and represent the clinical operations team in cross-functional team meetings.
- Establish and manage relationships with CROs, vendors, investigators, and other external partners.
- Provide oversight for project-related data integration/technology activities, including IVRS, ePRO, central lab, etc.
- Participate in discussions and help develop contingency/risk management plans for the clinical program.
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