Sagar Ghotekar

Background

About Sagar Ghotekar

I am a clinical research professional with 9+ years of experience in the life sciences and pharmaceutical industry. Beginning as a Clinical Research Coordinator, I’ve advanced to my current role as QC Associate Manager at IQVIA, leading efforts in clinical data quality, regulatory compliance, and trial documentation. I have managed end-to-end clinical trials (Phases I–IV) across therapeutic areas like oncology, infectious diseases, respiratory disorders, and chronic kidney disease. My work spans sponsor-led and investigator-initiated studies, with expertise in site coordination, regulatory submissions, data management, monitoring, and TMF oversight. At IQVIA, I drive operational excellence, support global study teams, and lead cross-functional initiatives to ensure inspection readiness, TMF quality, and data integrity. I’m also engaged in mentoring teams and implementing risk-based monitoring strategies. Previously, I held roles at Tata Consultancy Services and Syntel, where I contributed to project management, clinical system support, regulatory submissions, and TMF completeness. My clinical foundation was established at Ardent Clinical Research, with hands-on experience in subject recruitment, informed consent, and protocol execution. Core Competencies Clinical Trial Management (Phases I–IV, Observational, Late Phase) TMF Quality Control & Inspection Readiness Regulatory Compliance (ICH-GCP, USFDA, IRB/EC) Data Management & Risk-Based Monitoring Project Management & Cross-Functional Collaboration Vendor/CRO Oversight & Audit Support Study Start-Up to Close-Out Proficiency in CTMS, eTMF, EDC, and related systems