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Edwards Lifesciences Manager, Clinical Safety-Forecasted Opportunity in Irvine, California

This position has been posted in anticipation for future openings within Clinical Safety. If you meet the minimum job requirements, you will receive additional information about our Clinical Affairs Talent Community.

The Manager, Clinical Safety, will be responsible for management and oversight of all related Clinical Safety activities within assigned business unit. The Manager of Safety will also provide safety expertise to cross functional teams, including clinical trial management, data management, biostatistics, regulatory & medical affairs

Key Responsibilities:

• Manage and oversee the work of clinical safety team and may provide oversight and guidance cross functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department

• Develop and ensure alignment of safety processes (e.g., safety work instructions and documents, SOPs, charters) as needed. Identify risk, develop and lead in the implementation of clinical safety strategies which may include negotiations with internal and external parties

• Report adverse events and complaints according to regulatory requirements, trial safety processes and Edwards’ procedures. Respond to questions from regulatory authorities

• Monitor aggregate adverse events reporting rates and trends, including UADE/USADE determinations, assessment of seriousness, device and procedure relationship and report adverse events according to regulatory requirements, trial safety processes and Edwards’ procedures and determine whether CEC adjudication is required, if applicable. Assess individual adverse events, including those with complexity, and conduct Sponsor assessment utilizing clinical background and safety experience

• Create CEC or DMC presentations and narratives in partnership with key stakeholders (e.g., Safety Director, Clinical Affairs, Medical Safety Officer).

• Create and/or review medical narratives as needed for Clinical Safety Reporting and regulatory requirements, (e.g., APRs, RA reporting, CEC)

• Design training programs related to safety surveillance of the study and provide education to the sites in reporting adverse events

• Act as a liaison to key cross-functional stakeholders (e.g., PMO, Clinical Affairs, Regulatory Affairs, Quality, study sites leadership) regarding Safety-related matters

• Provide input on clinical trial design and safety sections of study protocols, CRFs, regulatory submissions, and clinical/regulatory reports and provide input to regulatory affairs questions on safety related issues

• Represent safety in internal and external audits

• Other duties as assigned by Management.

Education and Experience:

Bachelor's Degree in in related field previous related experience Required and

Demonstrated track record in people management Required

Master's Degree or equivalent in in related field Experience in Medical device or pharmaceutical industry, Clinical research, or in-hospital clinical and/or managerial experience Preferred

Experience working in a regulated industry Preferred

Additional Skills:

• Proven successful project management leadership skills

• Proven expertise in Microsoft Office Suite and related tools and systems

• 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 understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies while addressing issues with impact beyond own team based on knowledge of related disciplines

• Expert understanding of related aspects of clinical studies processes and/or systems

• Expert understanding of hospital environments and sterile techniques

• Expert understanding of medical terminology as it relates to clinical safety

• 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 to the business

• Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g. iMedidata)

• Excellent written and verbal communications skills

• Advanced problem-solving skills

• 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 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

• 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

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.

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