Role OverviewThe Clinical Program Manager (CPM) is a key member of Clinical Operations and will closely partner with the Senior Director of Clinical Program Management. The CPM will serve as the Global Study Lead for a large, global Phase 3 clinical study within a Phase 3 program, with accountability for the operational planning, execution, oversight, and delivery of the study.
What You Will Do
Serve as the Global Study Lead and primary Clinical Operations point of contact for a large, global Phase 3 study, providing end-to-end operational leadership from start-up through closeout. Lead global study planning and execution, including start-up, enrollment, site management, and ongoing study conduct through CRO partners.
Why It Might Be a Fit
The ideal candidate will have at least 8+ years of relevant clinical research experience and a BS, BA, BN in a relevant scientific discipline or an RN (2 or 3 year certificate).
Requirements
- At least 8+ years of relevant clinical research experience
- BS, BA, BN in a relevant scientific discipline or RN (2 or 3 year certificate)
- Relevant clinical trial experience supporting or leading a large, Global Phase 3 program in the pharmaceutical, biotechnology, or health care industry or equivalent.
- Strong operational leadership, problem-solving, and risk management skills with exceptional attention to detail.
- Experience with clinical trial inspection and audit readiness preferred.
- Strong knowledge of FDA/EMA regulations, ICH guidelines, and GCP requirements.
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