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Job Details

Manager Clinical Project Management NPD Remote - Transcatheter Heart Valves THV

Company name
Edwards Lifesciences

Location
Boston, MA, United States

Employment Type
Full-Time

Industry
Manager, Project Management, Healthcare, Clinical Research

Posted on
Jun 17, 2021

Valid Through
Sep 30, 2021

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Profile

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

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

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

Company info

Edwards Lifesciences
Website : http://www.edwards.com

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