Karen McCarthy Schau

Senior Director, Clinical Data Management @Vertex Pharmaceuticals

Cumberland Foreside, ME, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Aug 2023 — Present

Senior Director, Clinical Data Management @Vertex Pharmaceuticals

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EDUCATION

N/A

Boston College

Bachelor of Science

SKILLS

Data ManagementClinical OperationsClinical ResearchClinical Data ManagementPharmaceutical IndustrySopFdaRegulatory SubmissionsDrug DevelopmentGcpRisk-Based MonitoringClinical DevelopmentClinical TrialsCRO ManagementU.s. Food and Drug Administration (Fda)EdcTherapeutic AreasCtmsIch-GcpOncologyProtocolBiotechnologyCROClinical MonitoringClinical Trial Management System (Ctms)Life SciencesCross-Functional Team LeadershipElectronic Data Capture (Edc)Risk AssessmentGood Clinical Practice (Gcp)Training

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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Karen McCarthy Schau — Senior Director, Clinical Data Management at Vertex Pharmaceuticals in Cumberland Foreside, ME, US | Unifers