Job Purpose/ Summary: The Senior Clinical Project Manager is responsible for execution and oversight of assigned clinical trials (Phase I through Phase IV) to ensure client's goals of time, cost, and quality performance are met. The Senior CPM is expected to be independent but may require consultation and guidance from the trial-assigned Director to ensure successful clinical trial execution and to support other functional team members' management of daily trial operations. Often functions as a global lead to provide client interface and oversight of trial regions' operational activities. The Senior CPM is seen as skilled in the application of the essential functions of the CPM role listed below.
What You'll Do: - Manage the planning, implementation, execution, and close-out of assigned clinical trials (Phase I-IV), often functioning as a global trial lead.
- Provide operational oversight and coordination across functional teams and regions to ensure adherence to ICH-GCP, regulatory requirements, trial procedures, and contracted scope.
- Develop and maintain trial timelines, deliverables, resources, plans and budgets to ensure timely and high-quality execution.
- Serve as the primary operational-level client contact, leading study meetings, preparing project status reports, and supporting effective communication and documentation.
- Monitor project performance including timelines, KPIs, scope, budget, and vendor deliverables, escalating risks and issues to the trial-assigned Director as appropriate.
- Assess, mitigate, and proactively communicate trial risks and issues, driving timely action plans to support delivery of key milestones and quality expectations.
- Ensure inspection-readiness through oversight of TMF completeness, CRA activities, site performance, and compliance with project and communication plans.
What You'll Bring: - Bachelor's degree in allied health fields such as nursing, pharmacy, health or natural sciences, preferably with clinical trial management experience or an equivalent combination of education and relevant work experience
- At least 6 years of clinical research experience (CRO CRA or Research Manager, Site Research Manager, Central Clinical Research Laboratory Manager) or possesses transferrable skills and experience in project management in a clinical setting or relatable industry
- Graduate degree preferred
- Previous technical and managerial experience in conducting clinical pharmaceutical research studies at a CRO, in a hospital setting, or pharmaceutical company.
- Previous CRA experience preferred
- Experience or education indicating knowledge of medical and pharmaceutical terminology preferred
- Previous experience in a Clinical Project Manager level position preferred
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