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1.0 - 5.0 years
4 - 8 Lacs
Bengaluru
Work from Office
Role & responsibilities Manage and maintain Trial Master File (TMF/eTMF) documentation Upload, classify, index, and archive documents in Veeva Vault eTMF or similar systems Perform metadata QC and completeness checks based on ALCOA++ and TMF standards Conduct regular file reviews and identify missing/inconsistent documents Coordinate with study teams for timely document collection and updates Maintain Expected Document Lists (EDL) and completeness dashboards Support audit & inspection readiness activities Ensure compliance with ICH-GCP and regulatory guidelines Track document lifecycle and workflow status Provide reporting and updates to stakeholders Mentor/guide new team members when requir...
Posted 7 hours ago
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