LMK Team Spotlight Archive

Meet Jackie Morrill, TMF Consultant

Jackie joined LMK in early 2016 with nearly a decade of experience in clinical trial coordination and process improvement within the healthcare, biotech, and pharmaceutical industries. At LMK, Jackie’s focus is on process improvement and training for all aspects of the Trial Master File (TMF). Jackie’s recent appointment as one of LMK’s TMF University instructors has allowed her to combine her TMF expertise with her passion for teaching and mentoring. She has been busy working with the other instructors to develop a series of novice, intermediate, and advanced courses that cover many different topics including TMF Storage, Document Recognition, TMF Quality Control, Inspection Readiness, eTMF Best Practices, Current Regulations, TMF Metrics and more.

Prior to joining LMK, Jackie was a Senior Specialist in Document Quality and Process in Biogen’s Clinical Operations Department where she obtained her Lean Six Sigma Green Belt. During her years at Biogen, she developed a robust metrics and training program, facilitated the implementation of an electronic TMF (eTMF), coordinated the migration of 20+ paper and hybrid studies to the eTMF, completely revamped the TMF QC processes, and assisted with extensive inspection readiness preparation for FDA, MHRA, and PMDA inspections. Prior to Biogen, Jackie worked as a Clinical Research Coordinator at Children’s Hospital Boston and also at Dana-Farber Cancer Institute where she played a key role in starting the clinical research program within the LIVESTRONG Adult Survivorship Center.