Gaurav Jadhav

Senior Clinical Development Support Specialist @OXB

Oxfordshire, GB

Assisting Clinical Study Managers (CSM) for a daily clinical trials activity • Liaise with contracted CROs, vendors and contracted CRAs as necessary for trial documentations, monitoring visit activities, CRA handbooks to ensure adherence to protocols, monitoring plans and SOPs• Act as a primary point of contact for CRAs, clinical site staff, third party vendors and internal staff for trial, documents, monitoring visits, patient safety related queries• Facilitation of pre-study set up activities like vendor selection via RFIs, feasibility work, draft CDAs, protocol and synopsis preparation etc • Supporting CSM for creating, formatting & finalizing large or complex documents to tight deadlines e.g. protocols, Investigator Brochures etc.• Timely processing of drug requests for clinical studies, as agreed with assigned CSM.• Assisting CPMs to maintain & update study budget tracker, invoices, site supplies etc.• Devise and maintain study-specific tracking tools, as agreed with the assigned CSM• Co-monitoring study sites whenever required and necessary as agreed with CSM• Create and maintain paper and electronic Trial Master Files for all studies ensuring they are always Inspection Ready alongside the Clinical Study Managers• Periodic QC of all clinical study documents/TMF as required and QC of training files for Clinical Operations• Manage PV mailbox for safety alerts and safety exchange correspondence ensuring timely distribution• Acts as a Veeva RIM superuser, Q-Pulse (QMS) superuser, IFS superuser for the dept.• Qualified trainer for Veeva RIM, IFS, new starter, and other trainings for the dept. • Assist Regulatory team to compile paper or e-documents for Ethics Committee/IRB /Regulatory submissions for both paper and Veeva RIM• As a department training delegate, maintain the Clinical Operations and Regulatory training matrix and present data in departmental meetings• Assist in managing CAPA paperwork for Clinical Operations in Q-Pulse (QMS) system.

University of Pune

Bachelor of Pharmacy (B.Pharm.)

Kingston University

Masters