Sagar Ghotekar
Gcsm @Capgemini
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WORK HISTORY
Gcsm @Capgemini
Hyderabad, IN
Key ResponsibilitiesSupport clinical operations for global studies.Ensure compliance with regulatory standards and protocols.Maintain accurate documentation and inspection readiness.Communicate effectively with supply chain leaders, operational teams, and outsourcing partners.Adapt to changing priorities in a fast-paced environment.
EDUCATION
University of Pune
Bachelor of Pharmacy (B.Pharm.), Pharmacy
SKILLS
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 CompetenciesClinical Trial Management (Phases I–IV, Observational, Late Phase)TMF Quality Control & Inspection ReadinessRegulatory Compliance (ICH-GCP, USFDA, IRB/EC)Data Management & Risk-Based MonitoringProject Management & Cross-Functional CollaborationVendor/CRO Oversight & Audit SupportStudy Start-Up to Close-OutProficiency in CTMS, Veeva Vault eTMF, EDC, Medidata, Oracle, IVRS & IWRS, Risk Managment and related systems
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