Edwards has a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease. The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide.
This is an exciting opportunity within a company that leads the heart valve market, not only in terms of market share but also in cutting edge technology. The Transcatheter Heart Valve (THV) team extends Edwards’s leadership into the transcatheter area, providing immediate new treatment alternatives to patients with no or few other alternatives, eventually positioning THV as the treatment of choice for aortic stenosis.
Internally titled as Associate Manager, Clinical Affairs – the Clinical Project Manager of New Product Development, will lead a cross-functional project team to plan, execute and achieve Clinical objectives.
This role is based/located in Irvine, CA
**Essential Job Functions:**
+ 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 along with collaboration with the R&D cross-functional team.
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. Voice of Clinical Affairs in R&D team meetings.
+ 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.
+ A bachelor’s degree in related field required.
+ 8 years related experience including a minimum of 2 years project management experience required.
+ Previous clinical trial experience, particularly in medical devices and First in Man (FIM)/ Early Feasibility trials is preferred.
+ Completion of project management training preferred (PMP) is a plus.
**Additional Talents and General Expectations:**
+ 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% in US and Canada.
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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
Title: Clinical Project Manager of New Product Development, Clinical Research – Transcatheter Heart Valve (THV)
Location: USA-USA-California – Irvine
Job Number: 014831