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.
Meet Brandon Butler, TMF Support Analyst
Prior to joining LMK Clinical Research, Brandon spent nearly 8 years managing quality assurance and environmental inspection of sterile compounding facilities in accordance to FDA and State Boards of Pharmacy requirements. Brandon has expert knowledge of GDP, cGMP and USP <797>, and he holds several industry specific certifications. He has advised some of the world’s largest pharmaceutical manufacturers and leading hospital systems of cleanroom performance and design. Brandon transitioned his compliance expertise to the front end of drug development in 2015.
Clinical research allowed Brandon an avenue to transition his many years of pharmaceutical compliance experience to a new and fast-paced environment; he specifically found TMF to be an area of great opportunity within the industry. As a TMF Analyst, Brandon brings together an understanding of the FDA regulatory scheme and integrate that with particular client needs/priorities. He enjoys providing guidance to clients and persuading all stakeholders of the importance of TMF to a study.