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A Day In The Life Of A TMF Document Overview: Presented by Jackie Morrill
March 29 @ 11:00 am - 12:00 pm EST
In this webinar, we will follow a TMF document through its life cycle from creation through inspection. Along the way, documents maneuver through TMF submissions and quality checks utilizing well-developed processes, tools and metrics to ensure the TMF is ready when the inspectors come knocking. This presentation is a high-level overview of LMK’s pre-conference workshop at the 6th Trial Master File Summit in January.
Jackie Morrill is a Lean Six Sigma Green Belt certified clinical research professional with nearly a decade of experience in clinical trial coordination and process improvement within the healthcare, biotech, and pharmaceutical industries. In recent years, her dedicated focus has been on all things Trial Master File (TMF). Her experience includes oversight of electronic TMF (eTMF) implementation, coordination of a large migration project to move 20+ studies from a paper and/or hybrid TMF to an eTMF, development of a robust metrics and training program, a complete overhaul of TMF QC processes, and extensive inspection readiness preparation for FDA, MHRA, and PDMA inspections. Jackie’s broad knowledge base combined with her passion for teaching and mentoring qualify her to provide the highest caliber instruction to all of our students at the LMK TMF University.