Clinical Research Manager- FSP
Core
End-to-end project management for clinical trial protocols in a specific country, ensuring compliance with ICH/GCP and local regulations while driving execution from site selection to closeout.
Role type
Senior Clinical Research Manager (Country Lead)
Builds
Clinical trial studies for pharmaceutical/biotech clients
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
ICH-GCP compliance, project management, site selection and recruitment management, risk management planning, team leadership, regulatory environment knowledge, resource allocation, strategic thinking, conflict resolution, contract and budget management
Preferred skills
CRA experience, Master's degree or MD/PhD, project management certification
Technologies
Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF)
Responsibilities
Manage assigned protocols in compliance with ICH/GCP and country regulations; act as main point of contact between Country Operations and clinical trial teams; lead local study teams and train other roles; perform quality control visits and review monitoring reports; create and execute local risk management plans; collaborate with investigators and external partners; support local strategy development and sign contracts/manage budgets if delegated.
Seniority
Senior, hands-on IC with team leadership
