Project Lead, Clinical Operations Job in Dr Reddys Path Labs Private Limited

Job Description:

Identify different CRO/Vendors and roll-out RFI and RFP; Facilitate CRO/Vendor finalization Assess RFI/RFP information and shortlist CRO for further comparisions, discussions with HOD and senior leaders; Paricipate in vendor selection visits as Clinical Operations SME Contribute in developing Clinical trial execution startgeies/plan and also execute the clinical trials as per Clinical development startegies. Perform IP/RMP forecast for the entire project and monitor the inventory at depot and at sites to ensure adequate drug is available. Define various recruitment initiatives in coordination with CRO/vendor Contribute in review and finalization of various clinical trial documents/plans like Study Monitoring Plan, project management/communication plan, RACI etc. Review various project specific Work orders, Change Orders, study invoices etc. Ensure compliance of sponsor oversight plan by reviewing monitoring reports, CRF data, monthly listings/reports, perform onsite visits etc. Establish and maintain relationship with clinical trial sites Ensure all aspects of study site management i.e. recruitment of qualified investigators, site initiations, conduct investigator meetings, ensure enrollment criteria are met and other aspects of the study management as appropriate. Build and maintain good working relationship with CRO/Vendor; Prepare and conduct F2F meetings with CRO on need basis