Sr. Manager, Clinical Project Manager NPD (REMOTE) - THV
Company: Edwards Lifesciences Gruppe
Posted on: April 4, 2021
We have made changes to enhance your experience. If you have
applied for a job previously, you will need to create a new
account. Thank you for your patience. Sr. Manager, Clinical Project
Manager NPD (REMOTE) - THV USA - California - Irvine 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.-- --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
- 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
- Development: Build an effective and efficient clinical project
team. Provide mentoring and coaching to other project team
- Bachelor's Degree, twelve years' Clinical Trial experience
- Master's Degree, ten years' Clinical Trial experience
- Previous experience as a cross-functional PM leader is
- Clinical trial execution required. Preferred Qualifications:
- Lean Six Sigma belt is preferred.
- Experience working in a large manufacturing company
- 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
- 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
- Expert knowledge of regulatory submissions, reporting, and
- Represents leadership on projects within multiple areas,
interfacing with project managers, clinical team, and middle
- Provides leadership to outsourcing partners on a task level,
participates on a small-scale RFP.
- Ability to travel 30%
- Relocation assistance can be provided should you wish to
relocate E dwards is an Equal Opportunity/Affirmative Action
employer including protected Veterans and individuals with
disabilities. Posted 5 Days Ago Full time Req-3923 About Us 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.
Keywords: Edwards Lifesciences Gruppe, Irvine , Sr. Manager, Clinical Project Manager NPD (REMOTE) - THV, Executive , Irvine, California
Didn't find what you're looking for? Search again!