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Irene Lea Location
California, United States
Irene Lea Work
Senior Manager Clinical Data Management @ (March 2022 - Present)
Principal Clinical Data Manager @ (March 2021 - March 2022)
Clinical Data Management Consultant @ (September 2020 - February 2021)
CDM Contractor @ (July 2020 - September 2020)
Clinical Data Management Consultant @ (June 2020 - December 2020)
CDM Consultant @ (January 2018 - June 2020)
Senior Manager, Clinical Data Management @ (January 2016 - January 2017)
Manager, Clinical Data Management @ (January 2013 - December 2016)
Senior Clinical Data Manager @ (January 2013 - January 2015)
Senior Clinical Data Manager @ (January 2006 - December 2013)
Clinical Data Manager @ (May 2007 - April 2009)
Clinical Data Specialist @ (June 2006 - May 2007)
Senior Technical Writer @ (January 2000 - December 2006)
Irene Lea Education
Virginia Tech
Bachelor of Arts
University of Maryland
(Journalism)
Irene Lea Skills
Newsletters
21 CFR Part 11
EDC
Clinical Data Management
GCP
Clinical Trials
CTMS
Cross-functional Team Leadership
FDA
CRO
FrameMaker
Clinical Development
Software Documentation
Project Management
Databases
Document Management
CDISC
XML
Program Management
Computer System Validation
Enterprise Software
Quality Assurance
Medidata
Agile Methodologies
CRF design
Protocol
Oracle Clinical
Clinical Study Design
Electronic Data Capture (EDC)
Clinical Trial Management System (CTMS)
U.S. Food and Drug Administration (FDA)
Good Clinical Practice (GCP)
U.S. Title 21 CFR Part 11 Regulation
Editor
Technical Writer
Medical Devices
Data Management
Pharmaceutical Industry
Clinical Research
Oncology
Standard Operating Procedure (SOP)
Biotechnology
Management
Irene Lea Summary
Irene Lea, based in California, United States, is currently a Senior Manager Clinical Data Management at Silk Road Medical, Inc.. Irene Lea brings experience from previous roles at Silk Road Medical, Inc., Loxo Oncology, Inc., Gilead Sciences and Eyenovia Inc.. Irene Lea holds a Bachelor of Arts @ Virginia Tech. With a robust skill set that includes Newsletters, 21 CFR Part 11, EDC, Clinical Data Management, GCP and more. Irene Lea has 2 emails and 1 mobile phone numbers on RocketReach.
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