KSHITIJA BHOR

Operations Associate

Pune, Maharashtra, India1 yr experience

Key Highlights

Expert in Clinical Data Management with hands-on experience.
Proficient in Veeva Vault and Medidata Rave systems.
Academic top ranker with a strong foundation in Pharmacovigilance.

Stackforce AI infers this person is a Clinical Data Management professional with expertise in regulatory compliance and data validation.

Contact

Skills

Core Skills

Clinical Data ManagementClinical TrialsRegulatory Compliance

Other Skills

Veeva VaultTrial Master File (TMF)LongboatMedidata RaveDrugDevData ValidationData CleaningMicrosoft ExcelPharmaceutical database managementSharePointData AnalyticsPharmaceutical data mappingDrug database cleaningQuality control of pharmaceutical dataPharmaceutical data validation

About

I am looking for job opportunity in the Clinical Data Management domain with my experience in the clinical research field.

Experience

1 yr

Total Experience

1 yr

Average Tenure

Current Experience

Tata consultancy services

CTMS ASSOCIATE - Clinical Trial Management System

Dec 2024 – Dec 2025 · 1 yr · Pune

Uploading, reviewing, and approving clinical documents and updating information during startup phase in Veeva Vault 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.