Shrinivas Gadakari
Experienced Clinical Research Professional | Global Clinical Study Specialist | TATA Consultancy Services (TCS) |
- Role
- Global Clinical Study Specialist at Tata Consultancy Services
- Location
- Thane, IN
- LinkedIn followers
- 500 followers
About Shrinivas Gadakari
Skilled in Clinical Research. • Good leadership, Analytical & Problem solving…
Experience
Global Clinical Study Specialist
Apr 2024 — Present · Thane, IN
Facilitated the advancement of global sponsor-backed R&D clinical trials by providing support across various therapeutic areas.Conducted thorough quality checks and efficiently managed Trial Master File (TMF) documentation using the Regulatory Document Tracker (RDT), effectively resolving any documentation discrepancies.Streamlined clinical trial site activation in XPRESS and PMD systems post-regulatory approval, ensuring timely shipment of Investigational Products (IP).Produced critical operational reports, including monthly dashboards, comprehensive Investigator Lists, and detailed Administrative Tables.Ensured accurate maintenance of Veeva Vault CTMS, updating study milestones, scheduling visit events, and recording site details and personnel assignments.Acted as a key representative in monthly CTMS synchronization calls, collaborating with CROs and sponsor study teams to align trial processes.Managed electronic TMF responsibilities with precision, overseeing document transfers, Essential Document List (EDL) management, secondary quality control, and MVR uploads.Assisted in the review of site close-out documentation and contributed to the creation of end-of-study reports, ensuring compliance and completeness.
Education
National Institute of Management and Research Studies (NIMR)
Master of Science
2020 — 2022
Marathwada Agricultural University, Parbhani
Bachelor of Science
2010 — 2014
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