Serena Gervreau
Senior Manager, Clinical Affairs @Recor Medical
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WORK HISTORY
Senior Manager, Clinical Affairs @Recor Medical
Manage performance and development of in-house Clinical Trial Specialists • Determine project resources and manage clinical project tasks and prioritization• Contribute to development of study materials, start-up processes and strategies• Oversee study start-up, including the collection and filing of regulatory documents, contract and budget negotiations and site authorizations • Liaise cross-functionally, including Project Management, Safety, Data Management, Legal and Regulatory • Represent the Operations Team during project meetings• Collaborate with global partners to ensure consistency across geographies• Identify risks to project budget, timelines, and/or resources and develop mitigation strategies• Oversee maintenance of electronic Trial Master File (eTMF) to ensure audit readiness• Ensure team member training and project conduct according to internal SOPs and Work Instructions• Identify gaps and support best practices and process improvement initiatives • Provide input on structure of clinical department, roles and responsibilities and operational strategy• Oversee site and study closure process, including eTMF reconciliation, study supply returns, and systems deactivations
EDUCATION
Columbia University Mailman School of Public Health
Masters, Public Health
Connecticut College
Bachelor of Arts, Anthropology; Medical Anthropology
SKILLS
ABOUT SERENA GERVREAU
Experienced clinical research professional, with over 15 years experience within academia, medical institutions, and the medical device industry. Passionate about health and wellness.
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