Grace Crawford – VP Clinical Quality and Compliance
Grace joined MedImmune in April 2015 as head of the Clinical Quality & Compliance function responsible for supporting the Clinical Biologics area within MedImmune. Prior to that, Grace spent over 21 years at ICON where her main focus was leading the Clinical Quality Assurance Department. She is active in industry participating in forums such as the Society for Quality Assurance, the AVOCA Quality Consortium, and Linking Leaders Clinical “Quality” Roundtable. Before joining ICON, Grace was a medical technologist in the Clinical Laboratory at Bryn Mawr Hospital in Pennsylvania. She earned a Master of Science Degree in Clinical Microbiology at the Medical College of Pennsylvania.
Colleen has 20+ years of experience in information management, stewardship, and trial master file in the pharmaceutical industry. She is currently the Director, Trial Master File in Clinical Quality & Compliance at MedImmune, a member of the AstraZeneca Group. Colleen is responsible for global TMF operations, strategy and compliance. She has led the implementation of processes, metrics and several eTMF systems. She is a member of the DIA TMF Reference Model group and in the past served on the Steering Committee. She has implemented a TMF Master Index based the DIA Trial Master File Reference Model across numerous functions. Colleen received a B.S in Medical Technology from Fairleigh Dickinson University. She is also a Green Belt Certified Lean Sigma Instructor and is a Master Coach.
Owner and Principal Consultant- MULCAHY CONSULTING
Lisa has a 25+ year career in the pharmaceutical industry, primarily in the areas of clinical operations and quality management. Over 10 years ago she became an independent consultant, focusing solely on TMF process and management assisting biopharmaceutical R&D companies large and small with the assessment and improvement of their current state, establishing process where there is none, improving process to align with current standards, and the selection-implementation of systems for the management of electronic records of the TMF. She is experienced in the quality assessment of study-specific TMFs. She is a frequent speaker and experienced, accomplished workshop/course leader at TMF-related professional meetings.
Lisa is co-leader, with Karen Roy of Phlexglobal, as well as a Steering Committee member of the volunteer team of industry representatives through the DIA that created, maintains and expands the TMF Reference Model. She is the Chairperson of the DIA Document & Records Management Community.
Director, Clinical Trial Documents, Submissions and Disclosure- BRISTOL-MYERS SQUIBB
Rino Nascari – Director, Clinical Trial Documents, Submissions and Disclosure
Senior Manager, Clinical Operations- KYOWA KIRIN PHARMACEUTICAL DEVELOPMENT
Barbara Novak – Senior Manager, Clinical Operations
KYOWA KIRIN PHARMACEUTICAL DEVELOPMENT
Barbara has more than fifteen years of experience in Clinical Development and Clinical Research. She has been at Kyowa Kirin for the past ten years. In her role as Senior Manager in Clinical Operations, Barbara is the regional eTMF business administrator for the US and Europe regions.
She oversees a team of six Clinical Trial Managers and Trial Coordinators in all areas of assigned trial execution, implementation and conduct of open-label and double-blind, randomized multi-center, Global Phase I/II/III oncology and CNS – Parkinson’s disease clinical research trials. Barbara provides training and support to CROs and internal teams world-wide in collaboration with IT and other functions. Barbara collaborates with quality administrators at Kyowa Kirin’s headquarters in Japan to create SOPs that she continues to develop. Her other responsibilities range from site selection, vendor management, and study start-up to achieve successful project delivery. Of late, Barbara was charged with selecting and implementing an eTMF system that satisfied her company’s marketing and business needs.
Barbara’s prior roles have included time as a Clinical Trial Manager at Johnson & Johnson Pharmaceutical Research & Development and Clinical Research Associate at several different companies.
Barbara was also an Adjunct Instructor in Foundations of Clinical Research and Study Design. She received her Bachelor of Science degree from Rutgers University’s Douglas College. Barbara enjoys swimming, biking, gardening and nature.
Marie-Christine Poisson-Carvajal – Clinical Trial TMF Operations Lead
Marie-Christine Poisson-Carvajal is the Head of TMF Operations and the TMF Business Process Owner at Pfizer. She has been in the TMF space since 2011 as TMF Operations Lead. She is responsible for developing and executing strategy for continuous TMF quality and efficiency improvements, driving execution and performance data for all TMF roles and activities. ensuring TMF functions operate and perform to the level expected to contribute to high quality and inspection-ready TMF. For more than 25 years Marie-Christine has worked with different pharmaceutical companies and CROs in a variety of roles such as CRA, SOP and training manager, GCP quality auditor and project manager. Her experience has provided her with in-depth knowledge of clinical trials and their documentation. Besides her passion for TMF, Marie-Christine is always planning for a next travel or visit to her family in Europe.
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as CSO, she leads all Phlexglobal partnering across the clinical space, has key strategic input into the development of our eTMF, PhlexEview and serves as a Board member.
Karen was also responsible for the development of the TMF Reference Model, an industry driven initiative to standardize the content, naming and structure of Trial Master Files. She still chairs the management of the Model – a Model used by the vast majority of Pharmaceutical companies and CROs.
Karen graduated as a Pharmacist in South Africa and entered the Pharmaceutical Industry working for Eli Lilly in Sales. In 1992, she moved into Clinical Research in the UK with Chiltern International, initially managing the Clinical Development Department. Latterly she started up and globally managed a novel group, EDC Solutions, before joining Phlexglobal.
Director and Head of TMF Operations- DAIICHI SANKYO
Ms. Toth has over 18 years of IT experience in the pharmaceutical industry. She has been with Daiichi Sankyo, Inc. since 2016 as the Director/Head of TMF Operations; prior to that, she worked at Covance for 8 years within the Trial Master File space.
Ms. Toth is a Steering Committee member on the DIA TMF Reference Model Working Group and on the Operations Committee and a Director for the Health Sciences Records and Archives Association (HSRAA).
Ms. Toth 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 & Organizational Management from Drexel University, a Bachelor of Arts in Business and Technology from Fairleigh Dickinson University, and has an Associates of Applied Sciences in Computer Systems & Technology from Mercer County Community College.
In her spare time, she enjoys family time and watching her kids play soccer, basketball, and football.