Kshitija Bhor
Ctms Associate - Clinical Trial Management System & Etmf Management @Tata Consultancy Services
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WORK HISTORY
Ctms Associate - Clinical Trial Management System & Etmf Management @Tata Consultancy Services
Pune, IN
Uploading, reviewing, and approving clinical documents in Veeva Vault (TMF) at site, study and country levels-Managing ad hoc event creation, expected document count, key dates, and Regulatory pack i.e Essential documents customization & Uploading in TMF-Customizing and uploading Informed Consent Forms (ICFs), Tracking them and adding owning milestone in Veeva Vault-Handling FDA 1572-related activities and Site personnel updates (adding/debarring) in Veeva Vault-Uploading, reviewing, and approving documents in Longboat at site and country levels-Uploading, reviewing, and approving documents in DrugDev at site and country levels-Have hands-on expertise in Veeva Vault, Medidata Rave, and other EDC systems-worked on clinical database setup, UAT, and study start-up activities- I have performed data validation and applied data cleaning checks to ensure accuracy-managed query generation, review, and resolution with sites and CRAs.
EDUCATION
Shri bhairavnath secondary and higher secondary school, pune39.
HSC
Padmashree Dr. D. Y. Patil institute of pharmaceutical sciences and research pimpri 411018.
Bachelor of Pharmacy - BPharm
Shri ram madhyamik vidyalaya, pune39.
SSC
ABOUT KSHITIJA BHOR
I am looking for job opportunity in the Clinical Data Management domain with my…
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