Eleanor Clark Sub-Team Leader
Eleanor is Senior Director, Vendor Governance & Oversight at BioMarin, a global biotech company focused on genetically inherited diseases. Eleanor has worked across small and large biotech sponsor companies in various roles combining outsourced partnership development, process improvement and organizational transformation. This will be Eleanor’s third PCMG Assembly, having joined the Steering Committee in 2023.
Andrea Murison Sub-team Vice-lead
Andrea Murison is Senior Director of Business Development at Kayentis, with 16 years of experience in the field of Clinical Outcomes Assessments (COA). Andrea began her career focusing on licensing, copyright, and linguistic validation, later supporting teams specializing in qualitative research, developing and modifying COAs, psychometric analyses, and statistical analyses. This experience has helped her understand the importance of the application of metrology in Patient-Reported Outcomes (PROs). At Kayentis, Andrea leverages her experience in COAs to support the digital implementation of eCOAs in clinical trials. Andrea is delighted to continue to support PCMG – with the upcoming PCMG25 as her 4th assembly.
Birant Osman Sub-Team Vice-Lead
Birant Osman is a commercial leader with over 28 years experience in Research and Development. He has worked with some of the worlds most prestigious pharmaceutical, biotechnology and contract research organisations and helped bring some of the most innovative drugs to market. He has been attending PCMG for nearly 20 years and passionate about working with PCMG initiatives to help bring new innovative medicines to patients
Karen Roy Sub-Team Leader
Karen Roy was jointly responsible for the development of the CDISC TMF Reference Model, an industry driven initiative to standardize the content, naming and structure of Trial Master Files. She chairs the management of the Model and is currently working for CDISC supporting the transition of the Model to becoming a CDISC Standard.
Karen has also re-joined the Board of the Institute of Clinical Research, a UK-based association focussed on training and being a voice for Clinical Research, she consults for Epista, a team of experts working at the intersection of business priorities and compliance requirements and is on the Advisory Board of Pharmaseal, an eTMF and CTMS technology company.
Karen was previously responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for their Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and then strategy. In her role as CSO, she led all Phlexglobal partnering across the clinical space, had key strategic input into the development of their eTMF, PhlexTMF and served as a Board member.
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.
Dave Webber Sub-Team Leader
Dave has spent more than 30 years in the industry working for both Sponsors and CROs in roles spanning clinical operations, vendor compliance, outsourcing and business development. Dave is a long-standing member of the PCMG, a past Chairperson and recipient of the PCMG Lifetime achievement award. Dave is particularly interested in fostering more collaborative partnerships between sponsors and service providers.
