Serena Gervreau

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.

Experience

1. Senior Manager, Clinical Affairs

   Recor Medical

   Feb 2024 — Present

   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

  2006 — 2008

• Connecticut College

  Bachelor of Arts, Anthropology; Medical Anthropology

  1999 — 2003

Skills

• Clinical Research
• Public Health
• Irb
• Human Subjects Research
• Clinical Trials
• Medical Terminology
• Epidemiology
• Gcp
• Ctms
• Clinical Development
• Healthcare
• Medical Devices
• Health Policy
• Research
• Grant Writing
• Lifesciences
• Program Development