Edwards Lifesciences Mgr, Clinical Project Mgmt -THV (Remote) 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 Project Mangement Manager, you will lead cross-functional project teams to plan, execute and achieve Clinical objectives. Manage clinical trials activities and ensure all applicable regulatory requirements are met.
• Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables for larger or more complex clinical trials in accordance to GCP, all applicable regulations, and SOPs. Serve as the primary lead of assigned clinical trial(s)
• Provide direction, guidance, and oversight of clinical core teams to execute larger or more complex projects and initiatives. Determine clinical trial resources and set priorities for projects
• Manage project status and appropriate communication both internally and externally. May present trial information at executive and/or industry conferences
• Analyze trial performance to plan and develop corrective actions. Identify and communicate study risks, recommend and lead in the implementation of mitigation strategies in alignment with management
• Provide mentoring and coaching to other project team members
• Oversee the selection of clinical vendors and study sites
• Other incidental duties
Education and Experience:
Bachelor's Degree, ten years of Clinical Trial experience required
Master's Degree or Ph.D , eight years years experience required
Class II and III medical device experience required.
Certified PMP is preferred.
Clinical aptitude and strong PMO abilities preferred.
Lean belt or Six Sigma training is preferred.
Proven successful project management skills
Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Recognized as an expert in own area with specialized depth within the organization
Expert knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
Expert understanding of regulatory submissions, reporting, and audits
Ability to manage confidential information with discretion
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to manage competing priorities in a fast paced environment
Represents leadership on projects within a specific area interfacing with project managers and clinical team
Up to 30 travel%
Comprehensive relocation package available, should someone wish to relocate
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 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.