Edwards Lifesciences Analyst, Clinical Payments/Payment Triggers (Irvine, US) – Transcatheter Heart Valve (THV) in Irvine, California
Analyst, Clinical Payments (Irvine, US) – Transcatheter Heart Valve (THV)
Edwards is the global leader in THV (Transcatheter Heart Valve) replacement technologies designed for the non-surgical replacement of heart valves. Delivered via catheter while the heart is beating, these valves can enable patients to experience a better quality of life sooner than patients receiving traditional surgical therapies. Launched commercially in Europe in 2007, and in the United States in 2011, our transcatheter aortic heart valves are now available in more than 70 countries and are the most widely used transcatheter heart valves in the world.
The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide. As the Clinical Payments Analyst, you will develop, deploy, and maintain analytics system and provide analytics for clinical trial payments.
Responsibilities include, but not limited to:
Lead development of moderate to complex analysis, systems, and processes to drive global clinical trial payments including payment logic setup (CTMS, etc.), contract and budget development, preparation of analytics and reports, and other CTMS related activity; provide recommendations/awareness to management and/or key stakeholders.
Analyze patient data in clinical CRFs (Case Review Form) to determine alignment to protocol requirements.
Lead development of medium to large-scale new process design, improvements, and implementation in collaboration with cross-functional and cross BU teams; provide recommendations/awareness to management and/or key stakeholders.
Interact with global HCPs, clinical trial sites, and vendors as well as internal functions and management to resolve inquiries, including reconciliations, analytics, and other ad hoc requests.
Monitor and evaluate post process implementation performance and implement changes if necessary; provide recommendations/awareness to management and/or key stakeholders.
Provide training to team members.
Other incidental duties.
Bachelor’s Degree in related field with 3 years of related or clinical research experience OR
Master’s Degree or equivalent with 1 year of related experience or clinical research experience
Moderate knowledge of local and global regulations (e.g., AdvaMed, Anti-Kickback, Anti-Bribery, Sunshine ActComprehensive understanding of Good Clinical Practices, ICH guidelines, AdvaMed code, clinical research ethics, and patient privacy laws (plus applicable local regulations, when country-based)
Thorough understanding of clinical study protocols, clinical trial materials, and clinical costs
Moderate knowledge of concepts of clinical research and device development
Understanding of contracts and negotiations
Proven expertise in Excel and PowerPoint and other MS Office Suite apps including Word and Access
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving, organizational, analytical and critical thinking skills
Experience working medical device industry preferred
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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 is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.