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Data Integrity and Quality Management
Institute Day
TMF Collaboration
TMF Health
TMF Processes
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Donatella Ballerini
Chiesi
Head of GCP Compliance and Clinical Trial Administration Unit
Wendy Beeby
Takeda Pharmacueuticals
Director, Clinical Document Management and Trial Support
Daniel Bennett
Independent
TMF Manager
Mark Choe
Independent
eTMF SME, Inspection Readiness Expert, Veeva eTMF Analytics Expert,...
Grace Crawford
AstraZeneca R&D
Global Head, Clinical Quality & Compliance
Mary Emanoil
Pfizer
Head TMF and Registry Operations
Gillian Gittens
TransPerfect Life Sciences
Director, e-Clinical Strategy & Solutions
Rebecca Halbur, A.L.M.
Biogen
Assoc. Director, Trial Master File (TMF) Systems
Laura Hatcher
Spark Therapeutics
TMF Lead
David Ives
Alexion Pharmaceuticals, Inc.
Senior Director, Head of Clinical Operations Systems and Information...
Chris Jones
GSK
Director, Clinical Documentation
Aryn Knight
Texas Heart Institute
Administrative Director, Center for Clinical Research
Wendy Koc
Gilead
Associate Director, R&D, Quality and Compliance
Christa Lewiski
Seqirus
TMF Head, Study File Manager
Fiona MacKenzie
Alnylam
Manager, TMF and Document Management
Joanne Malia
Regeneron Pharmaceuticals, Inc.
Director, Clinical Documentation Management
Chaitanya Joshi MS MBA
bluebird bio
Senior Manager, eTMF Operations
Lauren Merrill, M.S.
Biogen
Associate Director, Records Management
Barbara A. Novak, BS MT(ASCP)
Kyowa Kirin, Inc
Associate Director, Clinical Operations Systems & Process
Laura Naranjo, M.S.J,
Daiichi Sankyo Pharma Development
Associate Director, TMF Operations, Clinical Systems & Records,...
Darshan Patel
IQVIA Technologies
Customer Success Leader, eTMF
Karen Roy
Phlexglobal
Chief Strategy Officer
Pawel Rucki
BASE Life Science
Senior Clinical Lead
Claire Schenkel
Alexion Pharmaceuticals, Inc.
Senior Manager, Clinical Operations System Integrity
Laurel-Ann Schrader
TransPerfect Life Sciences
Director, Client Solutions
Jamie Marie Toth, CPM, MS
Daiichi Sankyo, Inc.
Senior Director, Clinical Systems & Records
Wendy Trimboli
ACADIA Pharmaceuticals Inc.
Senior Director Clinical Operations Process, Systems & Inspection...
Sarah Tucker
Phlexglobal
Senior VP, Customer Success
LoriAnn Verna
Just in Time GCP
Director, TMF Operations and Quality Assurance
Keith Win, MS
Daiichi Sankyo, Inc.
Manager, Clinical Systems (eTMF)
