Saurabh Yadav

Senior Officer-clinical Trial Associate @Sun Pharma Advanced Research Company Ltd.

Mumbai, IN

Project Management support experience across global clinical trials, including Oncology Phase I studies, with involvement in budget negotiations and cross-functional coordination to ensure smooth study execution.Provide comprehensive administrative and operational support to Project Managers (PMs), Clinical Research Associates (CRAs), and senior team members for executing large-scale global clinical trials across various therapeutic areas.Perform site feasibility, site selection, site initiation visits (SIVs), monitoring assistance, and closeout activities and ensuring adherence to study timelines.Assist in study start-up, conduct, and closeout phases by collecting, preparing, reviewing, and maintaining essential documents while efficiently managing CTMS and EDC systems, and ensuring eTMF and ISF documentation are always audit-ready and compliant.Prepare and submit regulatory documents to Ethics Committees (ECs) to ensure timely approvals and site activations; collate essential documentation for Clinical Study Report (CSR) preparation.Identify and help resolve site-level issues, provide training support to site staff, and ensure sites have adequate resources and guidance throughout the study lifecycle.Maintain strict quality control (QC) over Trial Master Files (TMF) and Investigator Site Files (ISF) in alignment with ICH-GCP, SOPs, and regulatory standards.Conduct feasibility assessments to identify suitable research sites, verify site eligibility, and confirm their ability to meet study protocol requirements.Track and monitor subject recruitment progress, protocol deviations, visit compliance, and site monitoring schedules in collaboration with CRAs and Clinical Trial Managers (CTMs).Create and maintain project trackers, including Master Study Trackers, protocol deviation trackers, invoice reconciliation trackers, and essential documentation trackers.