About the RoleThe Senior Clinical Project Manager, Clinical Development is responsible for leading the planning, execution, oversight, and delivery of domestic and/or global postmarketing required clinical trials. The Sr. CPM serves as the operational leader for assigned studies, partnering cross-functionally with Medical/Drug Safety, Regulatory, Data Management, Quality, and external vendors to ensure clinical trials are delivered on time, within budget, and in compliance with applicable regulations and quality standards.
Key Responsibilities- Lead the operational execution of assigned domestic or global, multi-center late phase clinical trial(s) including oversight of selected vendor(s)/CRO to ensure accountability, quality, and on time delivery of key project deliverables.
- Develop and manage study timelines, contract/budget negotiations, and risk mitigation plans to ensure delivery on timeline and financial goals are met.
- Initiate and manage request for proposal activities for assigned clinical studies or clinical development vendors, including CROs, specialty lab vendors, bioanalytical vendors, etc.
- Lead study execution team comprised of cross-functional representatives from Regulatory, Drug Safety, Medical, Drug Supply, Data Management, Biostatistics, and Quality to oversee CRO vendors and ensure study excellence.
- Manage clinical development vendors according to vendor oversight plans.
- Oversee all study-level data monitoring activities, reviews monitoring visit reports, and conducts Sponsor oversight monitoring visits as required.
- Responsible for monthly Protocol Deviation (PD) review, including oversight of CRA documentation and collaboration with Medical Monitor for medical review.
- Prepares and/or reviews study-related study plans/documents; reviews site study documents.
- Assist in strategic trial design and protocol writing.
- Strategic country/site selection with program input and ensuring consistency across all clinical projects for therapeutic area.
- Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation including central clinical files, Trial Master File (TMF), and clinical trial registry submissions.
- Ensure inspection readiness and compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements.
Required Skills and Experience- Bachelor's degree in Life Sciences or a related scientific discipline (advanced degree preferred).
- 8+ years of Clinical Trial / Project Management experience within CRO, biotechnology or pharmaceutical organizations.
- Demonstrated experience operating at a Senior Clinical Trial Lead or Associate Director level.
- Proven leadership of global clinical studies and cross-functional project teams.
- Strong experience managing CROs, vendors, and external partners.
- Extensive knowledge of ICH-GCP, FDA, EMA, and global clinical trial regulations.
- Excellent communication, leadership, and project management skills.
Preferred Qualifications- 5+ years' experience of clinical trial management for late phase studies
- Experience with IMP/clinical drug supply logistics, planning, and labeling activities in late phase studies
- Effective communicator who can manage multiple priorities while building strong internal relationships across multiple departments
#LI-Hybrid
#LI-Full-time
