Kyowa Kirin Pharmaceuticals

Barbara Novak

System and Process Management Lead, Clinical Operations
Kyowa Kirin Pharmaceuticals

  • 20+ years of experience in Clinical Research and Development
  • Currently works as a Systems and Process Management Lead, Clinical Operations at Kyowa Kirin Pharmaceutical Development, Inc. since 2009
  • Oversees the Regional eTMF Business Administrator role in North America and Europe Region and core member who led the implementation of an eTMF system, globally. Oversee and provide training to support teams world-wide
  • Regional eTMF Lead to ensure TMF is inspection readiness for active studies at all times
  • Lead and oversee the internal/external partners to guarantee eTMF quality, accuracy and completeness for inspection purposes
  • Lead quality processes to ensure completeness, legibility, accuracy and retrieve-ability of study documentation throughout life of the trial, at study close-out and after proper archival.
  • Key NA/EU member of the Global CTMS and SOP Task Forces, Global Inspection Readiness and Risk Management Initiatives
  • Hold a Bachelor of Science in Medical Technology from Rutgers University, Douglass College
  • Enjoys family, swimming, biking, hiking, gardening and nature.

Barbara Novak’s Session(s)

11:45 am
Best Practices to Enhance Quality through a Compliant CRO, Sponsors, Site Collaboration

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