Edwards Lifesciences Manager, Clinical Affairs (Remote) -Critical Care in Irvine, California
This is a fantastic opportunity to join the Critical Care group, focused on advancing hemodynamic monitoring solutions and improving the quality and efficiency of care. With over 50 years of technological advances, Edwards Critical Care group continues to lead in this space by delivering cutting edge products that are powered with machine learning; evolve to less-invasive, and noninvasive devices; refine hemodynamic monitoring platforms; and provide evidence-based programs to enable proactive clinical decisions for surgical, anesthesia and critical care clinicians. Our products are used on millions of patients each year in over 80 countries around the world.
As the Clinical Affairs Manager you will be responsible for clinical trial management of multiple studies and may be 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 indirectly manage cross functional or matrix teams as appropriate.
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 larger or 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 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.
Oversee the selection of clinical vendors and study sites.
Bachelor's Degree Required.
Demonstrated track record in people management Required.
Master's Degree Preferred.
Experience working in a large manufacturing company Preferred
Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred
Proven successful project management skills.
Prior clinical research experience with Class III Medical Devices including PMA, IDE, 510k.
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.
Expert knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols while addressing issues with impact beyond own team based on knowledge of related disciplines.
Expert understanding of regulatory submissions, reporting, and audits.
Knowledge of financial mechanism that relates to clinical trials.
Demonstrated ability to manage assigned team 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 customers, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team.
Participate and present at meetings with internal and external representatives.
Resolve operational and scheduling issues.
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.
Develop relationships and leverage them to influence change.
Support and solicit input from team members at all levels within the organization.
Up to 30% Travel
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.