• Ensure standardization of procedures for CPU operations as per in- house SOP's and applicable regulatory guidelines. • Responsible for preparation and/or review of relevant standard operating procedures as per the current technicalities with respect to ICH GCP guidelines and other regulatory requirements. • Preparation, review, provide scientific inputs in the development of Protocol’s/ICD /CSR/FORBE and other study documents. • Coordinating with EC for approval of study documents. • Co-ordinating with designated pharmacist for receipt, verification, dispensing, retention of IP’s and ensure timely and prompt intimation to the sponsor for any discrepancies. • Co-ordination with BD/project management/sponsor for proper slotting of Clinical Studies. • Ensure the readiness of facilities with respect to administrative aspects (personnel, equipment’s, machines etc.), ICU along with emergency drugs, availability of an ambulance during conduct of study. • AE’s/SAE’s: Identification of AEs/SAEs and prompt management & timely notification of SAE to the EC/ sponsor/regulatory. • Review of clinical study reports, REMS, abbreviated clinical study reports, e CTD (Electronic Common Technical Document) Module- 2 & Module- 5 as per ICH GCP clinical and non-clinical overviews, safety reports, Investigator's Brochure (IB), periodic safety update reports as per applicable guidelines, and client specifications