Chaithanya S

Dedicated Clinical Data Management Associate with 3.3 years of hands-on expertise in analyzing Clinical Trials and Research, ensuring data quality and integrity in Veeva CTMS, Clinical Study Report and dataset creation from eTMF, Site updation, System administration, monitoring study start-up and close out phases, cross functional coordination and exceeded client expectations.

Clinical Data Management Associate - Accenture

(2021-01 - 2025-01)

• Worked closely on Veeva Vault CTMS updation at Study, Country and Site level, providing eTMF, RAVE and EDC access to users of different CROs, Drug Shipments.
• Updating document versions, IRB/IEC submission and approval dates, milestones and enrolment metrics.
• Producing Appendix 1.3 and 1.5, Financial disclosure tables and Office of Scientific Information for Clinical Study Report deliverables from eTMF and Client repository.
• Performed Site documentation reconciliation (FDA 1572/SIS Forms, CV, FDF, etc).
• Worked on CRO Portals of ICONMASTER, Paraxel, Phlex, PPD and Karuna PPD (eTMF) for producing Clinical study report and their submissions.
• Reviewing FDA 1572/Site Information Sheet data and updating it at site level.
• Site Management and Monitoring the phases till study close-out visits.
• Running Debarment checks for Investigators in fastTrack and Visual compliance and worked on SUSAR and Celalert SUSARs.
• Knowledge on database like RAVE (iMedidata).
• Conducted Trainings/Refresher trainings sand created guideline documents on the errors identified during the QC process.
• Performed Quality Check before the final submissions to the client.

Bachelor of Science - Genetics, Microbiology and Biochemistry - M.S. Ramaiah College of Arts, Science and Commerce, Bangalore (2021-01)

Pre-University Course - PCMB - Maharani Lakshmi Ammanni College, Bangalore (2016-01)

Secondary School - St. Philomena's English School (2013-01)