Headline

Clinical data specialist at Iqvia

About

Experienced Clinical Data Manager with 4 years of end-to-end expertise across the full lifecycle of clinical trials—including startup, conduct, and close-out phases—in neuroscience, immunology, oncology, and medical affairs therapeutic areas. Skilled in managing clinical databases and ensuring data accuracy and integrity, with hands-on experience in discrepancy management, tracker oversight, SAE reconciliation, vendor data integration, and documentation including test scripts, DVRs, and UATs. Proficient in Medidata RAVE and V-TMF repository, streamlining data workflows and enhancing operational efficiency. A collaborative team player with strong leadership and communication skills, adept at coordinating cross-functional teams to meet project timelines and deliver high-quality, compliant data solutions.

Location

Greater Bengaluru Area

Work experience

Clinical Data Specialist at IQVIA India, Mar 2024 - Present · 2 yrs 5 mos, Banglore

Senior Process Associate at Tata Consultancy Services, Oct 2021 - Feb 2024 · 2 yrs 5 mos, Thane, Maharashtra, India, • Creation of UAT plan, performing UAT. Preparing UAT Report. • Writing Test scripts • Performing TPV reconciliation with all the issue resolution from the Vendors, Monitors as well as the study team. • Query management performed very efficiently with all the queries being resolved by querying back to site, emailing to the Site Monitors, to the Study Team, Adding the issues to the clarification tracker, To Monitors issue log. • Email management (providing clarifications and resolutions to all the issues raised by the study team, the programmers and Monitors). • Requesting Reports from the programming team for various trackers and reports to be send to the study team. • SAE reconciliation performed independently with the thorough understanding of the issue resolution by safety team and study team. • Actively participating in the study calls and getting the issues clarified and providing clarification for various issues raised by the study team. • Study status reports/matrix and various other reports and process related trackers preparation. • Manual review of data listings. • Adhering to SLA's for all the activities. • Mentoring new team members

Data extracter at Bharari digital services, Aug 2019 - Mar 2020 · 8 mos, Gadhinglaj

Education

Master of pharmacy, Pharmaceutics, Sant Gajanan Maharaj College of Pharmacy, Chinchewadi, Mahagaon,

Bachelor of Pharmacy - BPharm, clinical data, Sant Gajanan Maharaj College of Pharmacy, Chinchewadi, Mahagaon,