Kristen has worked in Records Management for thirteen year. She began as a Document Coordinator in a construction company at a major pharmaceutical plant, from there into the role of Data Coordinator with a large CRO and eventually ended up in an entry level position at PSI Pharma Support America. In her eleven years at PSI she has helped initiate two eTMFs and currently hold the title Document Center Manager. Kristen is in charge of TMF operations for the North America, the United Kingdom, Latin America, and Australia while sharing lead responsibilities for Asia. She has been a member of the TMF RM Group since November of 2016 and has volunteered on the Change Control Board, Subtypes and the Framework for the Destruction of Paper for the DIA RM Community as well as serving on HSRAA Operations Committee as the Training Coordinator and the DIA RM Community Leadership Committee.
Martina Duevel – Systems Excellence Project Leader
Martina Duevel has been working in the pharmaceutical industry for almost 20 years in different roles in Clinical Quality Assurance and Clinical Project Management. In 2015 she lead the implementation of Bayer’s eTMF and subsequently headed the maturation program. In her current assignment as Systems Excellence Project Leader she is working on the integration of systems and processes for clinical operations.
Head of Global Documentation Quality Centre EU
Martin Hausten – Head of Global Documentation Quality Centre EU
Martin Hausten has been with Boehringer Ingelheim (Germany) since 2004.
He facilitated the set up of the BI TMF Governance Structure starting in 2013 and has been the Chair of the TMF Governance Committee since 2015, a global team of TMF SMEs, business process owners and Global Document Quality Centre leads.
Since March 2016, Martin has been the Head of the Global Document Quality Centre and has led the German team of Global Document Quality Specialists. He is active in the development, implementation and maintenance of Trial Master File (TMF) strategies.
He is experienced in setting up and maximizing outsourcing efficiency and efficacy models and best practices pertaining to TMFs.
Martin collected deep insight into clinical trial processes and CROs' quality management systems during his role as a GCP Auditor and Project Compliance Manager. Before that he was responsible for applying Computer System Validation Standards to systems used in GCP and GMP environments.
Martin studied Business Administration (Dipl. Betriebswirt), is a certified Auditor (DIN EN ISO 19011) and a certified Quality Manager (ISO DIN EN ISO 9000 family), and likes to practise sports.
Enablement Associate Director
Andreas Järemo – Enablement Associate Director
Head eDMS Center of Excellence/Regulatory Readiness
Timothy Rafferty – eTMF Quality and Metrics Manager
Tim Rafferty works at Roche in the Pharma Development eTMF Team. His main responsibility is to provide metrics around the use of the system by the Trial Teams. This means a focus on measuring the effectiveness of the many processes involved throughout a trial’s life cycle. He works closely with the business process owners to ensure that KPIs are monitored and met and that senior management are aware of any significant variances.
He has developed a suite of sophisticated near real-time dashboards, which have been instrumental in driving forward data quality. He has also worked closely with Process Management and Business Change Management streams to ensure that new approaches to the eTMF are widely adopted. Prior to his current role Tim worked in Regulatory Governance at Roche.
HEALTH SCIENCES RECORDS & ARCHIVES ASSOCIATION
Eldin began his records management career in 1986 at Glaxo. He held a variety of information and records management positions of increasing seniority, which continued following his move to Pfizer in 1993. His experience spans most areas of information and records management, including: DMSs and ERMS/EDMSs; file plans and retention schedules; classification schemes and taxonomies; microfilming; disaster recovery; data protection; imaging and workflow solutions; mergers and acquisitions; litigation support; change management; archive and active file management. In 2004, Eldin established Rammell Consulting, a management consultancy specialising in the provision of expert records management support, primarily to the pharmaceutical and biotech industries. He has worked with several companies on the development and implementation of eTMF systems and supporting processes.
Document Management Expert
Edith Tapie – Document Management Expert
Director and Head of TMF Operations
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.
Director, Head of TMF Management and Compliance
Wendy Trimboli – Director, Head of TMF Management and Compliance
Wendy has more than 20 years of major pharma experience in clinical research and clinical operations and has facilitated cross-functional teams, project teams and process improvement initiatives utilizing lean six-sigma methodology. She is a Steering Committee member of the DIA TMF Reference Model working group and has presented at numerous conferences internationally. In her current role at Eisai, she leads the group responsible for the global oversight of TMF management and archiving, and the quality control review process for clinical trial documents across all therapeutic areas. She is also responsible for oversight of the eTMF vendor and works closely with Eisai’s strategic CRO partners.
Principal Competency Development Specialist
Anne-Mette Varney – Principal Competency Development Specialist
Anne-Mette Varney is working as a Principal Competency Development Specialist and TMF Process Manager within Trial Management Anchor, Clinical Operations at Novo Nordisk A/S where she is responsible for building the TMF maintenance organisation in a global environment and for driving the TMF strategy and collaborate cross functional. Since 2012 she has been LoB PM in TMF Improvement Project optimising the TMF process and Inspection Readiness, supported a TMF IT Project as TMF process expert, conducted pilot on centralised QC and oversight, and leading the change process implementation in the global organisation. As background Anne-Mette holds a bachelor in Nursing and worked as a nurse for several years before moving to Pharmaceutical industry in 2000. During the past 18 years she has been working within Safety and Pharmacovigilance, Project and Program Management in CRO, and Clinical Operations as Senior International Trial Manager and TMF Process Manager.
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