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
• Assist in clinical trial disclosure and transparency activities
• Conduct Trial Master File (TMF) quality checks and ensure inspection readiness
• Participate in study close-out activities and contribute to the clinical study report
• Identify, manage, and document quality issues and deviations in collaboration with Clinical Quality Assurance (CQA)
• Support audits, health authority inspections, and related preparation activities
• Contribute to process improvement initiatives
• Perform other tasks as assigned by the manager or by appointment
• Maintain continuous personal and professional development related to clinical research and operations

Skills Required
clinical development, Stakeholder Management, Protocol Development, Risk Management