Santhini Sekar

TMF Lead @ Fortrea | 6+ Yrs Experience | eTMF Operations, Compliance, Inspection Readiness, TMF Automation & System Integrations

Role
Tmf Lead at Fortrea
Location
Chennai, TN, IN
LinkedIn followers
500 followers

About Santhini Sekar

I hold a Master’s degree in Science from Madras University and started my professional…

Experience

  1. Tmf Lead

    Fortrea

    Sep 2025 — Present · Bengaluru, IN

    I am currently working as a TMF Lead, where I oversee Trial Master File activities across clinical studies. I ensure that documentation is accurate, complete, and compliant with ICH-GCP and regulatory requirements. My role focuses on maintaining inspection readiness, driving quality, and supporting study teams with efficient document management. I collaborate with cross-functional partners to enable smooth trial operations and timely delivery. I also contribute to process improvements and optimize eTMF practices for greater efficiency. As a lead, I guide and support teams in strengthening TMF knowledge and best practices. This role allows me to play a key part in ensuring compliance, operational excellence, and successful study outcomes.

Education

  • University of Madras

    M.Sc, Botany/Plant Biology

    2017 — 2019

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