Varsha Jadhav
Clinical Data Manager @Tata Consultancy Services
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WORK HISTORY
Clinical Data Manager @Tata Consultancy Services
Pune, IN
Handling studies (Phase I to Phase IV) from set up, conduct, and close-out. • Participating in kick-off meetings, data management-related meetings, and internal discussions with study data management /Vendor/Client team to clarify the exact requirements. • Working on Biweekly reports such as Query Details Report, Stream query details, page status, etc. • Reviewing and updating all data management-related documents such as eCRF completion Guidelines, eCRF specification, ALS, SLACS (edit check configuration), DMP (Data Management Plan) and MDD (Visit matrix) • Performing UAT, manual checks/Data review standard/study-specific checks. • Performing query resolution, reconciliation/Sample reconciliation, and taking appropriate action.• Creates and updates File format specification document/ data transfer specification document.• Defines and identifies the study-specific data by reviewing the protocol, eCRF, and Matrix design document. • Performing early site closure, making sure all the items have been actioned from the close-out checklist.• Performing quality checks and providing technical expertise in troubleshooting the issues.• checks all inbound electronic data for any potentially unblinding data as defined in the protocol and ensures study integrity by sequestering unblinding data until data release is authorized. Performs edit checks. • Review and refine the technical requirements with a service provider to establish the transfer of the data and its transfer methodology. Configuration of the data loading tools based on data transfer specification.• Proactively develops contingency plans to reduce the impact of risks that may occur, analyze the effectiveness of strategies, and monitor and review risks.• Managed a team where I performed end-to-end activities from onboarding people, mentoring, training, leading a team, helping the team with the troubleshooting of the issues, and acting as a study lead during vendor calls.
EDUCATION
Satara College of Pharmacy
Bachelor's degree
Bharati vidyapeeth college of pharmacy C. B. D Belapur
Masters of Pharmacy
ABOUT VARSHA JADHAV
Clinical research professional with 7+ years of experience in different domains of Clinical Data Management of Clinical Trials.
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