Dhanasekar e

About Dhanasekar e

Clinical Research Professional with 2+ years supporting global clinical trial operations, TMF/eTMF quality, Project Management and site‑to‑sponsor coordination across the full study lifecycle• Project Management exposure through closely working with Clinical Trial Managers - maintaining study trackers, training matrices, CTMS updates, vendor coordination, meeting agendas/minutes, shipment tracking, budget/invoice tracking, and issue escalation• eTMF maintaining inspection‑ready documentation - Uploading, Indexing, QC, FR, Export and Reconciliation.• Skilled across clinical operations workflows: CRA support, monitoring‑visit prep/follow‑up, regulatory submissions, IP accountability, sample/inventory management, and EDC data verification• Proficient with major industry systems — Veeva Vault, Wingspan, Medidata Rave, Clario, Redcap, Argus, Octalsoft, SharePoint, Ambra, MS Office• Actively growing toward CTA → CRA career progression with strong interest in monitoring, site management, and operational excellence• Thrive in fast‑paced, global research environments with a focus on quality, collaboration, and patient‑centric trial execution For Professional enquiry and opportunities please reach out• Email: d••••••••@gmail.com• Phone:+91•••76 Location: Chennai, India

Experience

1. Tmf Specialist i

   ICON plc

   Nov 2024 — Present · Chennai, IN

   Manage and maintain Trial Master File (TMF) documents across clinical trials, ensuring accuracy, completeness, and compliance with ICH-GCP and sponsor SOPs.•Perform quality control (QC) reviews of essential documents and ensure timely eTMF filing using Veeva Vault•Support study teams by tracking document status, resolving discrepancies, and maintaining audit-ready documentation•Collaborate with cross-functional teams including CRAs, CTAs, Project Managers and Clinical Trial Managers to ensure alignment with trial milestones•Facilitate inspection readiness activities and assist with internal and external audits•Monitor TMF health metrics and contribute to continuous process improvement in document workflows•Maintain version control and metadata accuracy, ensuring ALCOA+ principles are followed

Education

• Manipal Academy of Higher Education

  MBA in Pharmaceutical Management , Pharmaceutical management

• Kerala vidyalayam higher secondary school

  HSC, Biology, General

• Nandha College of Pharmacy

  Bachelor of Pharmacy - BPharm, Bpharm

• Seventh Day Adventist Higher Secondary School

  ICSE, Science