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Manager, Clinical Affairs – Critical Care

Company Name: Edwards Lifesciences LLC
Location: Irvine, CA
Job Type: Salary Exempt/Full-Time
Contact Name: Mimi Omelas
Email: apply directly online (see below)

Job Description: 

Edwards Lifesciences Critical Care division has a unique opportunity for a Manager of Clinical Affairs to join our growing team, to be accountable for key study deliverables within timelines and budget. The Manager will conduct and report studies in accordance with all applicable regulatory requirements. The candidate will be adaptable and a problem-solver with the ability to work within cross-functional teams and to evaluate and manage research studies.


  • Clinical Study Execution, including Clinical Research Monitoring and Clinical Site Management.
  • Responsible for study start-up and study conduct activities including managing essential documents.
  • Manage study milestones, including accurate tracking and reporting of study metrics.
  • Execute site monitoring strategies, risk mitigation strategies, trial budgets, and site selection.
  • Generate and review of various site visit reports.
  • Investigate and execute resolutions for discrepancies in study documentation, by applying clinical protocol knowledge and GCP.
  • Managing and communicate the status of study progress and activities.
  • Maintains effective working relationships with affiliate teams, external CRO and co-development partner study teams.
  • Manage study timelines, resources, budget, risk and quality plans.
  • Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the Director.
  • Creates team culture, promotes team spirit.


Job Requirements:

 Required Education / Skills / Experience:


  • Bachelor’s degree in a life science or related field with a minimum of 10 years of medical device/pharmaceutical/biotech/CRO industry experience with a minimum of 5 years of study management experience managing complex international clinical studies.
  • Experience of project managing operational aspects of a clinical study including timelines, budgets and resource plans.
  • Strict attention to detail
  • Minimum of 5 years of independent monitoring experience as a CRA managing investigator sites.
  • Full understanding of regulatory submissions, reporting, and audits
  • Prior Medical Device Experience
  • Full knowledge and understanding of ICH and GCP guidelines 


  • Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification)
  • Knowledge of Cardiovascular Physiology and/or Hemodynamic Monitoring
  • Prior clinical research experience within Medical Devices including PMA, IDE, 510k  

Please apply online at: