Edwards Lifesciences Sr. Manager, Clinical Project Manager NPD THV in Irvine, California
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 NPD, you will be lead a cross-functional project team to plan, execute, and achieve clinical trial objectives.
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.
Bachelor's Degree, twelve years' Clinical Trial experience Required.
Master's Degree, ten years' Clinical Trial experience Required.
Previous experience as a cross-functional PM leader is required.
Clinical trial execution required.
Lean Six Sigma belt is preferred.
Experience working in a large manufacturing company preferred.
R&D engineering background or understanding of the full product lifecycle is preferred.
Certified PMP is a plus
Stout Clinical trial execution and strong PMO abilities 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.
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.
Ability to travel 20%
Based in Irvine, CA- relocation to Sunny CA provided
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 13,000 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.