Edwards Lifesciences Sr Manager, Clinical Project Manager 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. Manager, Clinical Project Manager you will be responsible for clinical trial management of multiple studies and the subject matter expert for assigned clinical studies including the planning, implementation, oversight, project management and completion of clinical trials
• Manage and oversee the work of team and may have financial budget responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department.
• 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, larger and more complex clinical trials through experienced team members 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 high-profile, larger and more complex projects for multiple clinical studies and initiatives. Determine clinical trial resources and set priorities for projects
• Manage project status and appropriate communication to influence both internally and externally including key opinion leaders. Present trial information at executive and/or industry conferences
• Analyze trial performance to plan and develop corrective actions. Anticipate and communicate study risks and lead in the implementation of mitigation strategies
• Oversee the selection of clinical vendors and study sites
• Manage and oversee the preparation of clinical portions of IDE and PMA submissions
• Other incidental duties
Bachelor's Degree and twelve years’ experience of previous related experience required OR
Master's Degree and ten years’ experience of previous related experience required.
Demonstrated track record in people management required.
Experience working in a large manufacturing company 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 problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Green or Black belt preferred
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Expert knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols while identifying applications of functional knowledge and existing methodologies to complex problems
• Expert understanding of regulatory submissions, reporting, and audits
• Knowledge of financial mechanism that relates to clinical trials
• Demonstrated ability to manage one or more teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of clinical trials to the business
• 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 work and excel within a fast paced, dynamic, and constantly changing work environment
• Frequently interacts with internal and external management and senior-level stakeholders concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications
• Lead briefings and technical meetings for internal and external representatives
• Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship
• Dedicated to quality client service and pro-active and responsive to client needs.
• Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
• Provide leadership and direction to cross-functional teams to successfully implement global enterprise systems and related solutions
• Develop relationships and leverage them to influence change
• Support and solicit input from team members at all levels
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
• Based in Irvine, CA- relocation to Sunny CA provided.
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.