Senior Clinical Project Manager

The 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.

Responsibilities

Lead the operational execution of assigned domestic or global, multi-center late phase clinical trial(s) including oversight of selected vendor(s)/CRO; Develop and manage study timelines, contract/budget negotiations, and risk mitigation plans; Initiate and manage request for proposal activities for assigned clinical studies or clinical development vendors; Lead study execution team comprised of cross-functional representatives to oversee CRO vendors; Manage clinical development vendors according to vendor oversight plans; Oversee all study-level data monitoring activities, review monitoring visit reports, and conduct Sponsor oversight monitoring visits as required; Responsible for monthly Protocol Deviation (PD) review, including oversight of CRA documentation and collaboration with Medical Monitor; Prepare and/or review study-related plans/documents and site study documents; Assist in strategic trial design and protocol writing; Strategic country/site selection with program input; Ensure all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs, including coordinating resolution of audit findings and audit-ready trial documentation; Ensure inspection readiness and compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements

Requirements

Bachelor's degree in Life Sciences or a related scientific discipline; 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

Nice to have

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