Job Summary RTL Sr RTL is responsible and accountable for deliveries of studies allocated to RCO unit performing end to end study related project management for studies managed in-house with-in agreed timelines budget and desired quality standards For Outsourced study RTL Sr RTL will be responsible to provide an effective Sponsor Oversight and accountable for key deliverables and study success RTL Sr RTL is expected to adhere to required procedures and quality in compliance with Sun Procedural Documents ICH-GCP and local regulations Area Of Responsibility Planning and Execution of trials as per agreed timelines budget and ensuring Quality across processes Planning and Facilitating HA submission in coordination with IRA team Perform Preliminary site feasibilities ensure site database is updated on periodic basis with feasibility results Plan and Accountable for the conduct of Site Selection visits ensure actions from SSV s are followed up Planning and performing IRB submissions in an efficient manner to secure timely approvals ensure IRB IEC dossiers are prepared and submitted as per requirements Ensure Translation process are followed up for all trial related documents Track all vendor related payments and ensure timely payments Negotiate study budgets with sites ensure Clinical Trial Agreements are executed in timely manner Ensure CTRI related submissions and updates in a timely manner for respective projects Facilitate SUGAM related submissions and updates with IRA team Responsible for preparing all project plans prior to SIV and training trial teams on the plans Ensure implementation of plans and updates if required during the course of trial Ensure planning and conduct of Monitoring visits as per Monitoring plan devise study specific remote monitoring plans and guidelines Provide periodic updates to management on study progress deliverables risks and Quality Collaboration and lead communication with cross-functional units IRA clinical sciences team Quality DM an
📌 Sr. Regional Trial Lead (Gurugram)
🏢 Sun Pharmaceutical Industries
📍 Gurugram
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