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Manager, Clinical Project Management NPD (Remote) - Transcatheter Heart Valves (THV)

Edwards Lifesciences LLC

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Edwards has an exciting opportunity in the Transcatheter Heart Valve (THV) group focused on developing minimally invasive solutions for patients suffering from structural heart disease. As the Manager, Clinical Project Management, you lead a cross-functional project team to plan, execute, and achieve clinical trial objectives within New Product Development portfolios. 

Key Responsibilities

  • Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables for larger or more complex clinical trials in accordance to GCP, all applicable regulations, and SOPs. Serve as the primary lead of assigned clinical trial(s)
  • Provide direction, guidance, and oversight of clinical core teams to execute larger or more complex projects and initiatives. Determine clinical trial resources and set priorities for projects
  • Manage project status and appropriate communication both internally and externally. May present trial information at executive and/or industry conferences
  • Analyze trial performance to plan and develop corrective actions. Identify and communicate study risks, recommend and lead in the implementation of mitigation strategies in alignment with management
  • Provide mentoring and coaching to other project team members
  • Oversee the selection of clinical vendors and study sites


Basic Qualifications

  • Bachelor's Degree with 10 years or Master's Degree with 8 years of clinical trial experience
  • Proven experience as a cross-functional project management leader
  • Class II and III medical device experience

Preferred Qualifications

  • Demonstrated track record of people management experience and strong leadership and coaching ability
  • Certified PMP
  • Lean belt or Six Sigma training

Additional Skills

  • Recognized as an expert in one or more areas with broad-based advanced knowledge within the organization
  • Proficient in the usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file)
  • Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills to drive achievement of objectives
  • Recognized as an expert in one or more areas with broad-based advanced knowledge within the organization
  • Expert knowledge of regulatory submissions, reporting, and audits
  • Provides leadership to outsourcing partners on a task level, participates small-scale RFPs
  • Up to 30% travel
  • Comprehensive relocation package available should someone wish to relocate

For Colorado Residents Only:

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

The base pay range for this position is $135,000 to $157,000

Additional information can be found through the link below:

https://www.edwards.com/careers/benefits

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

Manager, Clinical Project Management NPD (Remote) - Transcatheter Heart Valves (THV)

Edwards Lifesciences LLC

Apply now