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

  • Edwards Lifesciences
  • Irvine, CA, USA
  • Jul 20, 2020
Full time Health Care

Job Description

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

Have you been searching for a role that brings you to the forefront of innovation? We have an outstanding leadership opportunity for you to join an early-stage medical device team boldly designing transcatheter mitral and tricuspid therapies from the ground up!

The Transcatheter Mitral and Tricuspid Therapies (TMTT) division are passionate about developing breakthrough solutions for patients suffering from structural heart disease. Join this rapidly growing, fast-paced, dynamic team - and play a pivotal role in managing Edwards Lifesciences sponsored clinical studies, bringing new medical devices from concept to commercialization.

As the Clinical Trial Manager, you will be accountable for crucial study deliverables with timelines and budget. Conducting and reporting studies according to 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. This role is a brand-new leadership position with a unique opportunity to build your team!

Responsibilities include, but not limited to:

  • 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
  • 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
  • 30% travel within the United States

Minimum Education Requirements: 

  • Bachelor’s degree required
  • Minimum of 10 years of medical device/pharmaceutical/biotech/CRO industry experience.

Preferred Qualifications: 

  • Five years of study management experience managing multiple clinical studies.
  • Sponsor related expertise in full cycle Clinical Study Execution, including Clinical Research Monitoring and Clinical Site Management of Investigator sites.
  • Knowledge of Cardiovascular Physiology and structural heart anatomy is a strong preference
  • Prior clinical research experience with Class III Medical Devices including PMA, IDE, 510k is a strong preference
  • Ability to travel 30%

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.