Project Manager - FSP Trial Lead - Remote based in the US
Core
Lead cross-functional clinical trial projects ensuring delivery of quality, time, and cost objectives while managing vendor relationships and customer expectations.
Role type
Senior Project Manager (Clinical Trial Lead)
Builds
Clinical trial deliverables across phases I, II, and III
Domain
Biopharmaceuticals / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial management, risk assessment, contingency planning, vendor management, financial stewardship, regulatory compliance (ICH-GCP), cross-functional leadership, therapeutic area knowledge
Preferred skills
Advanced degree, Investigator site experience, Functional Service Provider (FSP) experience, Neurology therapeutic experience, Rare-disease experience
Technologies
Microsoft Outlook, Word, Excel, PowerPoint
Responsibilities
Implement and execute study plans, ensure adherence to escalation pathways, manage Out-of-Scope activity and Con Mod negotiations, drive risk identification and issue resolution, ensure team compliance with SOPs and regulatory requirements, manage vendor relationships, delegate and prioritize workload in changing environments
Seniority
Senior, hands-on IC