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A Day in the Life of a TMF Document Overview
December 1, 2016 @ 9:00 am - 10:00 am EST
In this webinar, we will follow a TMF document through its lifecycle 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 TMF 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.
Jeanmarie has over 10 years’ experience in the pharmaceutical industry providing support for clinical trials in all phases of development. She has almost 20 years of business experience, including her work outside the pharmaceutical realm where she led the migration/document management team from a paper to paperless environment, developed new processes and document management workflows. She has specialized in leading high priority projects which includes analyzing and process improvements, streamlining large volume of tasks while maintaining integrity of information, metrics collection/distribution, training development and mentoring. For over 5 years, her focus has been with TMF related tasks including reconciliation, working with project teams and/or CRO’s to rectify issues, FDA submission, TMF QC and study review. She is always excited to share her knowledge and to be a part of the LMK TMF University Team.