Clinical Team Manager FSP - Country Study Manager
Core
Lead and manage the operational implementation of Phase I-IV clinical studies within a specific country, ensuring high-quality execution, budget adherence, and regulatory compliance.
Role type
Senior Country Study Manager (Clinical Operations)
Builds
Country-level clinical study plans, budgets, and operational delivery for global R&D trials
Domain
Clinical Research / Pharmaceutical Development
Required skills
Project management, Vendor management, Budget management, Regulatory compliance (ICH-GCP), Site selection and management, Risk assessment, Cross-functional leadership, Strategic planning
Preferred skills
Therapeutic area knowledge, Local market expertise, Negotiation, Training and development
Technologies
Clinical trial management systems, Budgeting software, Communication tools
Responsibilities
Conduct country/site feasibility and lead site selection; Develop and manage country study plans, budgets, and forecasts; Manage local vendors and Clinical Trial Agreements; Ensure regulatory submissions and ethics committee approvals; Coordinate local study operations, monitoring, and safety reporting; Escalate issues and communicate status to central teams.