Gunvantsing Deore
Clinical Research life science
- Role
- Clinical Research Etmf Associate at Tata Consultancy Services
- Location
- Pune District, MH, IN
- LinkedIn followers
- 500 followers
About Gunvantsing Deore
Experienced eTMF professional with hands-on expertise in managing end-to-end electronic Trial Master File operations for global clinical trials within a regulated environment. Demonstrated proficiency in ICH GCP, TMF Reference Model, and ALCOA+ data integrity principles, with strong experience in risk-based quality control, document lifecycle management, and inspection readiness. Proven ability to collaborate with cross- functional teams to maintain audit-ready TMFs, ensure regulatory compliance, and support high-quality clinical documentation delivery.
Experience
Clinical Research Etmf Associate
May 2025 — Present · Pune District, IN
Managing electronic Trial Master File (eTMF) activities in compliance with ICH-GCP and regulatory guidelines.Preparing and maintaining Excel-based dashboards, trackers, pivot tables, and reports for operational monitoring and document status analysis.Analyzing clinical and operational data to identify trends, discrepancies, pending activities, and process gaps.Performing data validation, document indexing, classification, and quality checks to ensure accuracy, completeness, and consistency of records.Conducting QC reviews of clinical documents to ensure ALCOA+ compliance and regulatory readiness.Monitoring KPIs, turnaround timelines, reconciliation metrics, and compliance indicators using Excel and eTMF, CTMS systems.Supporting audit and inspection readiness by generating reports, tracking documentation status, and maintaining accurate records.Collaborating with Clinical Operations, QA, and Regulatory teams to resolve data discrepancies and improve workflow efficiency.Assisting in process improvement initiatives through data-driven analysis, reporting, and operational coordination.Utilizing analytical and problem-solving skills to support healthcare operations, documentation workflows, and compliance management.Working with large datasets and operational records to support reporting, tracking, and business decision-making activities.
Education
JAI HIND JUNIOR COLLEGE DHULE
HSC, SCIENCE
2018
Canossa Convent High school Dhule
10 th std, SSc
Yadavrao Tasgaonkar Institute of Pharmacy
Bachelor of Pharmacy
2020 — 2024
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