
Michael Chou Ms Mis
Specialties: Expert of EDC and eDiary implementations under GCP, especially on CFR 21, part 11. CDISC standards implementation.... | New York City Metropolitan Area, New York City Metropolitan Area, United States
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Michael Chou Ms Mis’s Emails mi****@ba****.com
Michael Chou Ms Mis’s Phone Numbers No phone number available.
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Michael Chou Ms Mis’s Location New York City Metropolitan Area, New York City Metropolitan Area, United States
Michael Chou Ms Mis’s Expertise Specialties: Expert of EDC and eDiary implementations under GCP, especially on CFR 21, part 11. CDISC standards implementation. Computer system validation and audit, including CAPA. Clinical Data Management and biometric operation in Phase 1 to 4 studies including Oncology, from clinical study design; study start up (including external data, biomarker, ECG, imaging setup); data validation report; protocol deviation and clinical study report. Vendor selection and qualification to implement quality by design and patient-centric design. Analytical skill to define KPIs for effective measures, including hands on to use ML/AI to train and fit a model using Python.
Michael Chou Ms Mis’s Current Industry Bayer
Michael
Chou Ms Mis’s Prior Industry
Merck Sharp And Dohme
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Merck
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Schering Plough
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Johnson And Johnson
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Bayer
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Work Experience

Bayer
Lead CRO Oversight Management
Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Bayer
Associate Director of CRO Oversight and Management
Sun Jan 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Bayer
Principal Data Manager
Tue Jan 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Bayer
Sr. Project Data Manager
Mon Sep 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Johnson And Johnson
Manager, Clinical Affair
Mon Jan 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)
Schering Plough
Project Manager
Mon Jan 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
Clinical Data Manager
Fri Aug 01 1997 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Nov 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck Sharp And Dohme
Research Associate
Sun Aug 01 1993 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Aug 01 1997 00:00:00 GMT+0000 (Coordinated Universal Time)