Abhilasha Roy
Document Specialist | Veeva Vault | eTMF QC Reviewer
- Role
- Document Specialist (Etmf) at IQVIA
- Location
- Thane, IN
- LinkedIn followers
- 500 followers
About Abhilasha Roy
Detail-oriented TMF Analyst with 2 years of experience in Electronic Trial Master File…
Experience
Document Specialist (Etmf)
Dec 2023 — Present · Thane, IN
Perform detailed quality checks of documents submitted for filing and uploaded into the TMFs•Perform mandatory checks on all imported documents as per the defined QC checklist/criteria (eg scanning, legibility, completeness, duplicates etc)•Communicate internal quality findings regarding the record to TMF importers for corrections•Maintain a track of QC check failed documents (rejected) and provide the same to the sponsor/TMF manager/TMF importer for resubmissions•Approve the documents for next stage of document life cycle•Ensure that TMF filing is consistent with established processes and TMF specifications•Provide support and feedback to study teams and TMF manager- IQVIA onresolution of Quality issues•Monitor TMFs for trends, quality, and completeness•Coordinate internal QC reviews of TMFs to ensure compliance and inspection readiness•Verify essential documents are included in the TMF and are in the correct Official Repository at close-out verification•Mentoring and training the new joiners in the team.
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