Sign up  

Manager, Clinical Affairs – Transcatheter Mitral and Tricuspid Therapies (TMTT)

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

Job Description

This is an exciting opportunity for you to join a team boldly designing transcatheter mitral and tricuspid therapies from the ground up.  Edwards’ Transcatheter Mitral and Tricuspid Therapies team is deeply dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives around the world.  

Edwards Lifesciences Transcatheter Mitral and Tricuspid 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, will be adaptable and a problem-solver with the ability to work within cross-functional teams and to evaluate and manage research studies.  The successful hire will manage a pivotal trial and build their awesome team. 

Responsibilities: 

  • 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
  • Creates team culture and promotes team spirit
  • Up to 50% US Travel



Job Requirements

Required: 

  • 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 clinical studies.
  • Experience working on IDE studies that comply with IDE regulations.
  • Prior clinical research experience within Medical Devices

 Preferred: 

  • Independent monitoring experience as a CRA managing investigator sites.
  • Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification)
  • Knowledge of Cardiovascular Physiology and structural heart anatomy is a strong preference
  • Prior clinical research experience within Medical Devices including PMA, IDE, 510k is a strong preference 

 

Please apply online at: https://edwards.taleo.net/careersection/jobdetail.ftl?job=015183&lang=en