Jamie Toth is Global Head, Trial Master File Management & Records at BeiGene, home based in New Jersey, USA. Prior to joining BeiGene she was with Daiichi Sankyo, Inc., where she implemented global systems (eTMF, CTMS, Safety Notifications) and processes and was responsible for TMF Operations, clinical systems, and records management within the R&D space. Jamie is a Steering Committee member on the CDISC TMF Reference Model Working Group, the Chair of the Operations Committee and a Director for the Health Sciences Records and Archives Association (HSRAA) and has led many industry workstreams for TMF/eTMF including the clinical trials email guidance. She led and published the TMF Plan Template revision 2 with industry colleagues. Jamie is also on the Board of Directors for the Association for GxP Excellence (AGxPE). Jamie is a Certified Project Manager (CPM), a trained Six Sigma Green Belt, and is PROSCI certified. She received her Master’s Degree in Clinical Research & Organi
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