Edwards Lifesciences Senior Manager, Clinical Program Management - Transcatheter Heart Valve 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 Sr. Clinical Project Manager, you will lead cross-functional project teams to plan, execute and achieve Clinical objectives.
- Planning: Develop detailed project plans to meet clinical objectives based on cross-functional input and analysis.
Through collaboration and influence, gain core team buy-in and team ownership of the plan.
Scope: Protocol writing, enrollment, monitoring, data cleaning and lock, biostats, safety, clinical submission deliverables, etc.
Team Leadership: Lead cross-functional core team meetings. Build the following within the team: meeting discipline (agenda, minutes, action items) and team esprit de corps, problem solving culture and accountability.
Performance measurement and Risk Mitigation: Analyze performance to plan and develop corrective action plans for any variances with the core team. Identify forward looking risk and determine mitigation plans with core team.
Communication and Reporting: Maintain weekly status reports, including timelines and performance dashboards.
Maintain efficient and effective communication, per communication plan development and execution, to provide clarity for roles and responsibilities and alignment with stakeholders.
Requires a minimum four years of medical device project management experience.
A bachelor's degree is required. Previous clinical trial experience, particularly in medical devices, is preferred.
Completion of project management training preferred (PMP) is a plus.
Must be proficient in computer skills in Microsoft Project, Excel, Word, and PowerPoint.
Ability to work independently and as an active member and leader of the team is essential.
Ability to address delicate situations and effectively manage conflict to maximize project team progress.
Ability to lead and motivate others to action.
Comfortable with a dynamic, fast paced environment.
Effect problem solving. Defining problems, developing solutions, weighing options and presenting recommendations.
Effectively communicate orally and in writing to all project stakeholders.
Must be able to interact with high profile investigators in a positive and constructive manner.
Travel up to 25%
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.