Job Description
Roles & Responsibilities:
- Execute assigned clinical trial operational activities in collaboration with the Clinical Operations Associate Director (COAD)
- Coordinate with External Service Providers (ESPs) to ensure timely delivery of outsourced tasks
- Contribute to or oversee key trial documents such as protocols, informed consent forms, project plans, and safety management plans
- Participate in trial feasibility assessments, country allocation, and site selection
- Assist in study budget tracking including processing invoices and accruals
- Coordinate the development and execution of the GCP Sponsor Oversight Plan
- Plan and support clinical trial quality risk management activities
- Oversee outsourced monitoring activities and conduct sponsor oversight visits to identify and resolve study-level, site-level, and CRA-level issues
- Support Investigational Medicinal Product (IMP) planning and management
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