Wendy Beeby – Director, Clinical Document Management, Inspection Readiness and Trial Support
Wendy Beeby is Director of Clinical Document Management, Inspection Readiness and Trial Support at Takeda, responsible for the strategic direction of clinical document management, Trial Master File and Trial Support working in collaboration with functional leads to implement effective inspection readiness and support plans.
With a career of over 25 years working in the pharmaceutical industry, Wendy has enjoyed building customer focused teams which provide expert guidance and support on trial support, records management and inspection preparedness.
In collaboration with TMF expert vendors, Wendy has developed innovative models for TMF quality review which can adapt quickly to fast growing organization. Having implemented eTMF, she more recently focused on an eTMF migration solutions to support outsourced trials. Wendy has enjoyed working with core team experts in company acquisitions and has implemented strategies for the integration of clinical records, systems and teams.
Global Head of Clinical Quality and Compliance- ASTRAZENECA
Grace Crawford – Global Head of Clinical Quality and Compliance
As the Global Head of Clinical Quality & Compliance, Grace is accountable for the development, implementation, maintenance and adoption of quality management services for Development Operations, R&D. Grace has extensive experience leading global teams accountable for quality management systems, compliance, and delivery of high quality, GCP inspection ready clinical studies. She is passionate about creating a quality mindset and raising awareness to make a positive impact to the quality culture in organizations. Before the AstraZeneca re-organization in 2019, Grace was the head of Clinical Quality & Compliance at MedImmune (the Biologics science unit within AstraZeneca) since April 2015 responsible for supporting the Clinical Biologics department. 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, often chairing or presenting at conferences, and participates in forums such as the Society for Quality Assurance, the AVOCA Quality Consortium, and Linking Leaders Clinical “Quality” Roundtable discussion.
Martina Duevel – Systems Excellence Project Leader
Martina Duevel has almost 20 years of pharma experience. In her current role as Systems Excellence Project Leader at Bayer she is responsible for eTMF Innovation and its integration into the R&D system landscape and involved in other projects driving digitisation. In 2015 she lead the implementation of Bayer's eTMF and subsequently headed the maturation program.
Martina has started her Industry career in Clinical Quality Assurance where she worked as an auditor for studies, vendors, and systems, as trainer of auditors and as internal GCP consultant for process changes, inspections, and SOP development. In 2008 she moved into Clinical Project Management were she was overseeing operations for clinical development projects in oncology and diagnostic imaging from early planning through submission and inspection. In 2014/15 she led a group of clinical trial coordinators and clinical records coordinators managing study TMFs.
Martina has studied Biochemistry and earned a doctorate (Dr. rer. nat) from Free University Berlin and worked in several research institutions were she gained her first GxP experience. She is a certified Project Manager as well. In her spare time she enjoys spending time with her family, singing in a choir, and gardening.
Liz is a Sr. Manager within in the TMF organization at Biogen and currently oversees TMF process and quality for phase I-IV trials to ensure ongoing compliance across the organization. During Liz’s 5+ years at Biogen, she has supported numerous regulatory inspections (FDA, MHRA, PMDA), has supported development of a TMF metrics program and has worked cross-functionally on TMF management with CROs. Additionally, Liz has driven implementation of a global eTMF at Biogen, and built a team of TMF Study Owners to support day-to-day TMF activities on the SMT level. She obtained a BE in biomedical engineering from Vanderbilt University, and is currently an MBA candidate at Worchester Polytechnic Institute.
Prior to her work at Biogen, Liz was a research coordinator at Vanderbilt University Medical Center’s Clinical Research Center, and held clinical trial and TMF management roles at Lantheus Medical Imaging and Aveo Oncology.
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.
Senior Director, Head of TMF and Registry Operations- PFIZER
Marie-Christine Poisson-Carvajal – Senior Director, Head of TMF and Registry Operations
Marie-Christine Poisson-Carvajal is the Head of TMF & Registry Operations and the TMF Business Process Owner at Pfizer. She has been in the TMF space since 2011. 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 35 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.
Bryan Souder is Director, TMF Head at Merck & Co., INC., USA. He has a BS from Radford University, a Six Sigma Greenbelt, and 22 years of clinical trial research experience. His current focus is being TMF Head. Prior to leading the department Bryan was the eTMF “Global Implementation Lead” Merck & Co., Inc. He has conducted eTMF application & process training in 18 countries and has hosted multiple sponsor inspections.
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