Ankita Hore

I am a detail-oriented clinical research professional with over two years of experience managing Trial Master File (TMF) activities within global CRO environments. I bring strong expertise in Veeva Vault eTMF and PhlexEview, combined with a solid grounding in ICH-GCP and TMF Reference Model standards.

In my roles at IQVIA and ICON Plc, I led TMF quality reviews, monitored document accuracy and completeness, and coordinated cross-functionally to resolve document gaps and ensure sponsor requirements were met. I have prepared guidance documentation for onboarding and mentored team members in TMF processes and system usage.

I have actively supported inspection readiness, audits, reconciliations, and TMF close-out and archival activities, maintaining SLA adherence and effective sponsor communication. My background in microbiology also adds laboratory and documentation rigor to my clinical research work.

I am committed to maintaining high-quality documentation, ensuring regulatory compliance, and improving TMF processes to support reliable clinical trial recordkeeping and successful regulatory interactions.