Naseem Ansari
Clinical Trial Document Specialist | eTMF, Veeva Vault, FirstDoc, CTMS | QC | Audit Compliance |Inspection Readiness & Regulatory Excellence @ Tata Consultancy Services | Bachelor of Pharmacy
- Role
- Record Management Specialist at Tata Consultancy Services
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Naseem Ansari
As a record management specialist at Tata Consultancy Services (TCS), I manage electronic…
Experience
Record Management Specialist
Jul 2022 — Present · Thane, IN
Managed electronic trial master files (eTMF) using First Doc, Wingspan, Intelligent eTMF, and Veeva Vault, ensuring completeness, accuracy, and compliance with GCP and ICH guidelines.Hands-on experience in filing and managing records within the Veeva Vault Clinical Operations Suite, specifically within Veeva CTMS, eTMF, and Veeva Site Connect.Conducted initial and final checks for records before Study/Country/SIV initiation, maintaining high standards of documentation.Collaborated as an LTRS liaison between study teams and trial documentation service teams, ensuring effective communication and timely resolution of issues.Played a key role in quality control review (QCR), ensuring that records are checked for accuracy and compliance before finalization.Managed record distribution through Veeva Site Connect, ensuring documents are assigned appropriately based on applicability, study requirements, and regulatory needs.Skilled in handling clinical trial data and processes across pharmaceuticals, ensuring accuracy in record filing and addressing missing record issues in collaboration with relevant stakeholders.
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