Sanjiv Kumar

• Manage setup, maintenance, and closure of electronic Trial Master File (eTMF) repositories per study SOPs and TMF plans.

• Conduct document indexing, QC, and completeness checks across multiple studies.

• Coordinate with clinical operations and regulatory teams to resolve document discrepancies.

• Drive audit and inspection readiness through TMF quality oversight and compliance tracking.

• Train new hires and serve as SME for Veeva Vault and ELVIS systems.

• Generate TMF status, quality, and performance reports for leadership and sponsors.

TECHNOLOGIES

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• Acted as TMF point of contact for assigned studies, managing document accuracy and completeness.

• Performed TMF quality reviews, health checks, and internal audits per ICH-GCP and sponsor SOPs.

• Monitored TMF metrics, developed reports, and contributed to CAPA implementation for findings.

• Coordinated data migration between eTMF systems and supported study closeout activities.

• Worked closely with cross-functional teams to ensure documentation compliance and timely reconciliation.

TECHNOLOGIES

Veeva Vault | WINGSPAN | Documentum | eTMF Migration Tool | SharePoint | MS Excel

• Conducted and monitored clinical studies in compliance with ICH-GCP and sponsor protocols.

• Reviewed CRFs, ICFs, and study protocols ensuring accuracy and completeness of TMF documentation.

• Managed AE/SAE reporting, protocol compliance, and subject safety during trials.

• Conducted site quality checks, data validation, and supported audit and inspection preparation.

• Supervised sample collection, IP accountability, and data verification activities.

TECHNOLOGIES

CTMS | Excel Site Tracker | eTMF | MS Word | MS PowerPoint | Audit Log Templates