Shahaji Shendkar

Clinical Process Associate @IQVIA

Thane, IN

Assist GTM in planning, maintenance, and closeout activities for global clinical trials.• Manage study-level documents and ensure eTMF completeness and quality.• Track subject/site status, protocol deviations, and visit milestones in VEEVA VAULT.• Prepare compliance reports and support training metrics (e-Trainings, CRA/SRS access).• Review site feasibility and investigator selection with GTMs.• Mentor new joiners and serve as SME for internal systems and workflows.• Working on Start-up, Enrolment open, & Closed (DBL) studies to procure all documents whichever applicable to file in eTMF.• Perform Veeva EDC data entry as applicable.• Ensure compliance with Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.• Participate in audits and inspections, providing necessary documentation and support.

Swami Ramanand Teerth Marathwada University

Bachelor of Pharmacy - BPharm