This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly. Summary LI Hybrid The Manager, Clinical Sciences is responsible and accountable for execution of assigned clinical research tasks related to Investigator-Initiated Trials (IITs), Research Collaborations (RCs,) and Non-Interventional Studies / Local Interventional Studies (NIS/LIS). Manager, Clinical Sciences role is critical to support the growing complexity and volume of clinical studies (IITs & RC), evidence generation activities, and cross-functional collaborations. This position will provide dedicated clinical operations oversight to ensure high-quality study execution, timely deliverables, and compliance with regulatory and organizational standards. About the Role Key Responsibilities: Accountable for the accuracy and timeliness of trial information in all trial databases and tracking systems. Facilitates Medical Review Committee (MRC) and Scientific Review Committee (SRC) review of concepts.
Interfaces with the disease area(s), global and US clinical team members, regulatory affairs, drug supply, data management, finance, and other relevant functional areas. Preparation of trial related documentation, Trial Master File (TMF) maintenance: project files including ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment. Ensures key processes and documents are maintained/updated on time (e.g., Third Party Study Report (TPSR), Informed Consent Form (ICF) Clinical Review, TMF). Ensures TPSR & Pubs review. Initiation of Investigational Current Drug (IND) x-ref letter and Investigat
📌 Manager, Clinical Sciences (India)
🏢 Novartis
📍 India
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