Global Director Clinical Trials @ (February 2025 - June 2026)
Global Clinical Affairs Manager @ (March 2024 - February 2025)
Director Clinical Affairs @ (October 2021 - March 2024)
Senior Clinical Training Manager and Senior Clinical Affairs Manager @ (July 2017 - October 2021)
Clinical Site Manager @ ReliantHeart Inc. (July 2015 - July 2017)
Clinical Project Manager @ LoneStar Heart, Inc. (December 2013 - June 2015)
Principal Clinical Site Manager @ Respicardia INC (May 2011 - February 2013)
Principal Clinical Site Manager @ Paracor Medical (September 2009 - May 2011)
Clinical Site Manager @ Paracor Medical (September 2007 - September 2009)
Senior Clinical Research Specailist @ (January 2002 - January 2007)
Karen Stephens Education
Bethel University
BSN (Nursing)
Karen Stephens Skills
ICH
Electronic Trial Master File (eTMF)
Timelines
Operational Strategy
Clinical Supervision
Medical Research
Communication
Clinical Study Management
Team Management
Regulatory Compliance
Cardiopulmonary
Technological Innovation
Clinical Affairs
Medical Mission Coordination
Startups
CRO Management
Auditing
Project Management
Electronic Data Management
Protocol Development
Adverse Event Reporting
Committees
Manuscript Development
Virtual Training
Training Material
Vendor Management
Cross-functional Collaborations
Clinical Training
Presentation Skills
Teamwork
Standard Operating Procedure (SOP)
Research Skills
Contract Research Organization (CRO)
Cross-functional Team Leadership
Heart Failure
Hospitals
Nursing
Medical Devices
Clinical Trials
Clinical Research
FDA
Cardiology
Leadership
Protocol
CTMS
Clinical Monitoring
Clinical Development
Biotechnology
GCP
Regulatory Affairs
Data Analysis
Microsoft Excel
Program Management
Integration
Karen Stephens Summary
Karen Stephens, based in United States, is currently a Director, Clinical Affairs at Thrombolex, Inc.. Karen Stephens brings experience from previous roles at Corvia Medical, Inc., Acutus Medical, Inc. and Lungpacer Medical Inc.. Karen Stephens holds a BSN in Nursing @ Bethel University. With a robust skill set that includes ICH, Electronic Trial Master File (eTMF), Timelines, Operational Strategy, Clinical Supervision and more. Karen Stephens has 2 emails and 2 mobile phone numbers on RocketReach.
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