Karen McCarthy Schau
Senior Director, Clinical Data Management @Vertex Pharmaceuticals
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WORK HISTORY
Senior Director, Clinical Data Management @Vertex Pharmaceuticals
EDUCATION
Boston College
Bachelor of Science
SKILLS
ABOUT KAREN MCCARTHY SCHAU
Clinical Research/Clinical Management Professional with 25+ years diversified experience across functional areas and global regions with current focus in Clinical Operations business process improvement, Digital Process Automation, and Clinical Systems deployment with emphasis on eTMF, Risk-Based Quality Management (RBQM), Investigator Portal, CRO Engagement and Clinical Architecture. Career includes 5 years eClinical systems and process consulting and 10 years specializing in process re-engineering and system implementation for a large global CRO and currently focuses on helping companies deploy solutions to streamline processes, improve productivity and operational efficiency, and better manage information. Progressive responsibilities in Data Management, Clinical Research including Clinical Trial Leader and Clinical Research Associate management oversight, IT Business Liaison for eTMF, Liaison for Clinical Japan eTMF and Global Process development and implementation including company launch of eTMF. Therapeutic Experience in Respiratory Diseases, Acute/Chronic Pain, Cardiovascular (in-patient), AKI (in-patient), CNS, Oncology, Anesthesia and Infectious Disease.
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