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Overview
Our client, a venture-backed clinical-stage biotech, is advancing its lead candidate into Phase 1 and needs a Senior Clinical Project Manager to run day-to-day delivery at US sites — initially freelance, with a route to permanent as the pipeline scales.
Key Responsibilities
• Own end-to-end operational delivery of the Phase 1 study across US sites
• Act as primary contact between sponsor, CRO, and clinical sites
• Manage timelines, budget, and risk log
• Lead US site selection, activation, and start-up
• Oversee vendors (central labs, IRT, imaging, etc.)
• Ensure GCP/ICH compliance and inspection readiness
• Chair cross-functional study team meetings
• Track enrollment and resolve site-level issues
• Report progress and risks to leadership
Requirements
• 7+ years clinical project management in biotech
• Direct experience running Phase 1 / first-in-human trials
• CNS, neurology, or immunology experience preferred
• Track record managing US-only site networks
• Strong CRO and vendor oversight experience
• Comfortable in a lean, hands-on biotech environment
Engagement
• Freelance/contract, with a defined path to permanent conversion
• Fully remote, US-based
• Start date and rate: TBC