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Trial Master File Summit 2021 has ended
avatar for Karen Roy

Karen Roy

PHLEXGLOBAL
Chief Strategy Officer
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, PhlexTMF and serves as a Board member.

Karen helped to spearhead and co-chairs the TMF Reference Model; an industry-driven initiative to standardize the content, naming and structure of TMFs. She remains an advocate and spokesperson for the TMF Reference Model; version 3.2, being released November 2020.

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.

My Speakers Sessions

Tuesday, October 26
 

9:00am CDT

6:15pm CDT

 
Wednesday, October 27
 

9:00am CDT

4:15pm CDT