Edwards Lifesciences

Manager

• Lead clinical studies, manage a team, and oversee statistical programming activities
• Lead programmers in developing program specifications and design documents with the project statistician
• Lead programming of analysis datasets across multiple clinical trials
• Serve as lead statistical programmer for specific projects as needed
• Manage and oversee a team of statistical programmers and matrix teams as appropriate
• Develop a talent development plan aligned with departmental functional growth strategies
• Provide programming expertise for clinical-trial analyses used in clinical study reports, presentations, and select publications
• Provide programming expertise for complex ad hoc data requests
• Identify risks and lead implementation of mitigation strategies, including negotiations with internal and external parties
• Ensure analysis data and programming code meet regulatory and company standards
• Ensure databases and external data sources meet analysis requirements across clinical trials
• Develop and revise statistical programming procedures or instructions
• Assist in compiling technical documents for internal and external audits
• Perform other duties assigned by Leadership
• Collaborate with cross-functional teams, customers, functional peer-group managers, and internal and external representatives
• Participate in and present at internal and external meetings

Senior Manager, Statistical Programming

Clinical Specialist

• Serve as a subject matter expert supporting the advancement of transcatheter therapies through hands-on clinical engagement, procedural innovation, and continuous learning
• Partner cross-functionally with physicians, R&D, and commercial teams to support complex cases, develop procedural techniques, and translate real-world clinical insights into device and therapy improvements
• Represent TMTT during complex research cases, clinical trials, and commercial cases with investigating physicians, hospital staff, and clinical research coordinators
• Provide on-site, real-time guidance during implants, including contingency planning for unforeseen occurrences involving novel devices
• Document procedural case observations and provide insights into post-procedural events
• Support enrollment discussions and issue escalation with Principal Investigators and research teams
• Develop materials and provide education on device handling, implantation, and troubleshooting techniques
• Develop, analyze, and optimize complex procedures, testing, and therapies using clinical imaging knowledge
• Coordinate clinical imaging training and instruction for cross-functional teams as products progress from ESAPCU to early human use and commercial settings
• Create complex design control and trial-related documentation
• Support complaint and investigational analyses and recommend improvements

Senior Specialist, Clinical Education, Clinical Development

Clinical Research

• Conduct field monitoring of studies and data collection for clinical trials
• Assess data documentation, reports, records, transcripts, and exam results for consistency with case report forms
• Determine whether clinical trial/study subject documentation aligns with the study hypothesis
• Monitor clinical trial/study safety in accordance with protocols, GCP, and regulatory requirements
• Provide oversight and insights into trial activities, including protocol compliance, enrollment, monitoring deviations, and data quality
• Report findings to principal investigators, support staff, sponsor management, leadership, Institutional Review Boards/Ethics Committees, Research Ethics Committees, and Clinical Operations
• Recommend and develop process improvements
• Verify trial/study data and maintain appropriate internal and external regulatory documents
• Audit sites for appropriate regulatory documentation and proper source documentation
• Validate investigational device accountability from Edwards through field sites and final disposition
• Develop and deliver training on GCPs, protocols, databases, compliance, device accountability, adverse event reporting, investigation protocols, amendments, and regulatory documentation
• Train and proctor new employees on trial- and study-related activities

Clinical Research Monitoring Specialist

Medical Director

• Direct medical affairs activities including scientific communications, medical information and scientific support for claims, and educational grants
• Lead the team in delivering clinical evidence to the physician community through impactful scientific communications aligned with Medical Affairs strategy
• Recommend and implement strategies, systems, and processes for scientific communications
• Lead assessment of clinical data and development and delivery of publications in peer-reviewed medical/cardiology journals and physician podium presentations
• Recommend and implement strategies, systems, and processes for medical information related to transcatheter tricuspid valve interventions
• Ensure provision of information supporting appropriate product use and scientific exchange
• Lead effective scientific review of product claims related to transcatheter tricuspid valve interventions
• Lead effective implementation of educational grant reviews
• Refine and implement best practices and methods through directors, managers, and experienced professionals
• Develop a talent development and succession plan aligned with Medical Affairs growth strategy
• Lead risk identification, mitigation strategies, alternative solutions, and issue resolution with cross-functional and matrix teams
• Plan and direct strategic activities and prioritize projects to meet business objectives
• Analyze, formulate, and present recommendations to guide leadership
• Develop and deliver senior leadership and executive-level communications

Senior Director, Medical Affairs

• Help make each site independent in procedures, product preparation and support
• Provide guidance on device use and train clinicians and staff on THV technology
• Travel frequently within the assigned territory after extensive training
• Work independently in valve crimping, case management, pre-case planning, post-case management, 3 Mensio management, Therapy Awareness program management and clinical education programs
• Implement sales and educational materials for clinicians
• Validate software and hardware updates in the field
• Plan and implement growth strategies within focused accounts with Sales Management
• Develop clinical champions among current and potential customers for THV products
• Deliver training and educational materials to clinicians to drive utilization of the Edwards THV product portfolio
• Educate physicians and staff to achieve expert proficiency in THV procedures and positive patient outcomes
• Attend implants; prepare and crimp Sapien valves for assigned cases; support physicians during THV procedures; manage complaint handling as needed
• Support cases outside the assigned region as needed
• Partner with Territory Managers on site selection criteria, therapy awareness programs and THV growth
• Partner with proctors and sales organization to plan and implement physician and support staff training
• Assist in developing the THV procedure in Cardiology and Surgery
• Collaborate with Sales, Clinical Affairs, Marketing, Quality, Regulatory and Education departments
• Report to an assigned Regional Director

Field Clinical Specialist, Transcatheter Heart Valve

• Conduct clinical monitoring activities at sites across Germany
• Serve as key contact to assigned clinical sites throughout the study process
• Achieve and report on agreed clinical milestones
• Support study team interactions with Ethics Committees and Competent Authorities
• Participate actively in project team meetings
• Collaborate closely with internal stakeholders to ensure proper project conduct
• Assist in providing site and Edwards personnel training
• Prepare and maintain study documents and complete forms
• Report site enrollment progress, device accountability, and protocol deviations
• Collect completed Case Report Forms and audit supporting documentation
• Process adverse events
• Document procedural case observations for post-procedural event investigations
• Perform data review, safety reporting, and complaint handling
• Identify and report adverse events and device-related complications
• Develop and implement improved processes
• Ensure audit readiness for internal, external, and site audits
• Perform other incidental duties assigned by management

Clinical Research Associate / Senior CRA

• Lead planning and execution of changes impacting Edwards' commercialized THV and/or TMTT product portfolios
• Manage large-scale to enterprise-wide programs and initiatives for global continuity of quality supply
• Ensure Global Supply Chain integration into product lifecycle management through collaboration with R&D, Marketing, Quality, Regulatory Affairs, Manufacturing, and other critical supply chain functions
• Provide engineering expertise using business excellence methods such as Six Sigma and LEAN
• Resolve manufacturing issues to ensure business continuity, product quality, and customer service
• Safeguard medical product design and manufacturing intent from suppliers through distribution
• Direct and guide project teams executing tactical Supply Chain projects and initiatives
• Ensure Manufacturing Readiness Reviews occur before major builds following operations changes
• Analyze and track progress against key business and operating metrics
• Provide input on executive summaries and recommendations for new projects, initiatives, and programs
• Escalate program risks to management when projects are not successfully executed or do not achieve anticipated outcomes
• Integrate process technologies and transfer stabilized products into and between Edwards Commercial Manufacturing facilities and External Manufacturers
• Drive product launches into additional markets
• Communicate risks and mitigations to stakeholders and Senior Leadership
• Partner with Finance to quantify budget needs, project resources, expenses, and capital expenditures