Clinical Trial Manager
Core
Operational coordinator for late-stage clinical trials, managing CROs and vendors to ensure study execution, deliverables, and timelines.
Role type
Senior Clinical Trial Manager (Sponsor-side)
Builds
Clinical trial operations for late-stage drug development programs
Domain
Biopharmaceuticals / Clinical Development
Deliverable
client delivery
Required skills
Clinical trial operations management, CRO/vendor coordination, study startup coordination, protocol deviation tracking, safety reporting coordination, TMF management, IRB/IEC tracking, enrollment metrics reporting, data reconciliation support, budget tracking, clinical trial systems proficiency
Preferred skills
Oncology/immunology/respiratory therapeutic area knowledge, sponsor-side experience
Technologies
CTMS, EDC, eTMF
Responsibilities
Serve as operational point of contact for CROs and vendors; review CRO-generated study documents for quality; coordinate study startup activities; maintain study trackers and action logs; track and triage protocol deviations; support safety reporting coordination; monitor TMF completeness; assist with IRB/IEC tracking; compile operational metrics; support data reconciliation and monitoring visit reviews; review vendor invoices and track budget.
Seniority
Senior, hands-on IC
