Clinical Operations Manager - Hyderabad / Secunderabad, Telangana - confidential

    confidential
    confidential Hyderabad / Secunderabad, Telangana

    3 days ago

    Full time Healthcare
    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
    • 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

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Clinical operations manager