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Sr Manager, Clinical Project Managment THV

Company: Edwards Lifesciences
Location: Irvine
Posted on: October 14, 2020

Job Description:

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 Senior Manager, Clinical Project Management, you will be lead a cross-functional project team to plan, execute, and achieve clinical trial objectives.

Key Responsibilities:

• Planning: Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables for high-profile, significant, and more complex clinical trials according to GCP, all applicable regulations SOPs. Serve as the primary lead of assigned clinical trial(s) Oversee selection of clinical vendors and study sites and preparation of clinical portions of IDE and PMA submissions

• Leadership and Accountability: Responsible for direction, guidance, and oversight of clinical core teams to execute complex projects for multiple clinical studies and initiatives

•Communication: Manage project status and appropriate communication both internally and externally, including key opinion leaders. Present trial information at the executive and or industry conferences

•Performance measurement and risk mitigation: Analysis trial performance to plan and develop corrective actions. Anticipate and communicate study risks and lead in the implementation of mitigation strategies

• Development: Build an effective and efficient clinical project team. Provide mentoring and coaching to other project team members.

Education and Experience:

• Bachelor's Degree, twelve years' experience of previous related experience Required.

• Master's Degree or equivalent, ten years' experience of previous related experience Required.

• Previous experience as a cross-functional PM leader is required

• Experience working in a large manufacturing company preferred

Additional Skills:

• Proven successful project management skills, certified PMP is a plus

• Clinical aptitude and strong PMO abilities

• Lean Six Sigma belt is preferred

• R&D engineering background or understanding of the full product lifecycle is preferred.

• 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) required

• 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

• Represents leadership on projects within multiple areas, interfacing with project managers, clinical team and middle management

• Provides leadership to outsourcing partners on a task level, participates on a small-scale RFP

• Adhere to all EHS rules and requirements and take adequate control measures to prevent injuries to themselves and others as well as to protect the environment and prevent pollution under their span of influence/control

• Ability to travel 20%

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

Keywords: Edwards Lifesciences, Irvine , Sr Manager, Clinical Project Managment THV, Other , Irvine, California

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