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.