Edwards Lifesciences Sr. Manager, Clinical Project Management (Remote) - Surgical in Irvine, California
“Helping patients is our life’s work, and your contributions directly impact our ability to transform patient care around the world.” – Michael A. Mussallem, Chairman and CEOEdwards is growing and has an exciting opportunity with our Surgical Structural Heart group, focused on developing new and maintaining the best standard of surgical and minimal invasive treatments for patients suffering from heart valve disease.The Manager, Clinical Project Management will be responsible for multiple studies and acting as a subject matter expert for programs and devices. Further, this role will lead and develop individuals to ensure the success of both Edwards and its employees. Key Responsibilities:
Manage and oversee the work of team and develop a robust talent development plan in alignment with functional growth strategies of the department
Provide direction, guidance, and oversight of clinical teams to execute large and/or complex projects and initiatives. Determine clinical trial resources and set priorities for projects
Develop and execute clinical strategies and project plans with accountability for all project deliverables
Serve as the primary lead of assigned clinical programs
Manage communication and relationships with internal and external stakeholders
Interact with senior-level stakeholders concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications
Influence the thinking of or gain acceptance from others in sensitive situations without damage to the relationship
Lead briefings and technical meetings for internal and external representatives
May present program/trial information to executive leadership and at industry conferences
Analyze trial performance to plan and develop corrective actions. Identify and communicate study risks as well as recommend and lead the implementation of mitigation strategies in alignment with cross-functional team
Oversee the selection of clinical vendors and study sites Minimum Requirements:
Bachelor's Degree required
5 years previous people leadership with direct reports is required
10 years of experience in clinical research with at least 5 in the medical device industry
Understanding of medical device development and clinical study design and execution
Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for direct report actions and for partnering with HR on employee relations
Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of clinical trials to the business
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Up to 25% travel Preferred Qualifications:
Cardiovascular medical device experience
Strong knowledge and understanding of international and domestic medical device regulatory guidelines relevant to clinical. Experience with and understanding of regulatory submissions, reporting, and audit processes
Ability to understand competitive landscape and contribute to the development of clinical research strategies to support stakeholder needs
Able to make decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment
Proven success managing complex global clinical programs
Ability to work and excel within a fast paced, dynamic, and constantly changing work environmentEvery employee is essential to Edwards’ success, and we’re ready to help you advance along your career path!
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.