Mruthyunjaya User

I’m a B. Pharm graduate with hands-on experience in TMF/eTMF operations, clinical documentation, and regulatory compliance within a GxP environment at Thermo Fisher Scientific (global CRO). I support pilot studies end-to-end, maintaining inspection-ready TMF records across 5+ concurrent studies while helping ensure ICH-GCP compliant workflows.

In my Project Support Coordinator (TMF Support Coordinator) role, I managed and maintained 2,000+ study documents across eTMF systems (PPD & client platforms), achieving zero critical findings across all managed pilot studies. I conduct TMF QC reviews and health checks, manage EDLs and document lifecycle across study, country, and site levels, and deliver weekly eTMF metrics and compliance reports for proactive audit readiness.

I also coordinate with cross-functional teams (data management, regulatory, site teams), resolve documentation gaps before audit windows, and investigate audit findings and eTMF discrepancies in collaboration with QA, clinical, and IT to reduce recurrence. Alongside training junior team members on eTMF workflows and SOPs, I bring applied Python and Machine Learning skills to clinical data analysis workflows.