Full time
Req-38556
2 days ago
Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
We are searching for a Clinical Site Payments Manager to join Edwards THV team. As a Clinical Site Payments Manager, you support the full clinical site payments lifecycle, including partnering closely with key stakeholders, including but not limited to, Project Teams, Contracts, Systems, Finance and Compliance groups to lead the execution of clinical site payments while applying clinical expertise. This is a hybrid role (office and remote blend). Selected candidate must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days.
How you’ll make an impact:
Provide direction and guidance to team members to execute payment activities, initiatives and/or programs; continuously monitor resourcing needs of team to ensure timely and on-going output; recommend temporary and permanent staffing solutions when applicable
Manage the end-to-end payments process that requires partnership with key stakeholders (e.g. Clinical IT, THV Clinical Systems, Contracts team, Finance) for implementation of clinical systems (e.g. Clinical Trial Master Systems) to effectively consult and approve clinical site payments on a global scale. Authority to execute payments in CTMS and COUPA based on functional guidelines
Support development of clinical trial site budgets per trial in the US and OUS throughout the study lifecycle in THV and with partnership on budget development for other functions as determined by business unit. Budget development includes utilizing fair market value platforms (i.e. IQVIA) with an in-depth understanding of clinical trial protocols in order to consult with stakeholders for compliant budgets for global trials
Identify and communicate risks with moderate-to-high exposure to the company. Create and implement corrective action plan to prevent future occurrence. Communicate risk(s) and course correction plan(s) to leadership and key stakeholders
Member of governance boards (e.g. CTMS) and administers company policies, system enhancements, and process improvements. Liaison for multiple business units to manage governance and point of contact for other business units. Provides recommendations for enterprise-wide system enhancement
Develops and manages training of the site payments processes while ensuring compliant payment practices globally
Other incidental duties
What you’ll need (required)
Bachelor's Degree or Equivalent in related field
8 years of related work experience with Clinical Payments, Clinical Study Agreements, Informed Consents, Consulting and/or Vendor contracts along with knowledge of supplier qualifications processes
What else we look for (preferred):
Direct people development experience
Experience with COUPA, CTMS
Understanding of clinical payment reconciliation and analytics
Master's Degree or equivalent of previous related experience with Clinical Study Agreements, Informed Consents, Consulting and/or Vendor contracts along with knowledge of supplier qualifications processes
Juris Doctor or equivalent of previous related experience with Clinical Study Agreements, Informed Consents, Consulting and/or Vendor contracts along with knowledge of supplier qualifications processes
Additional Skills:
Proven expertise in Microsoft Office Suite, fair market value platforms, and payment systems
Proven expertise in global site budget and template development
Excellent understanding of clinical trial protocols and knowledge of medical assessment terminology
Strong knowledge of healthcare compliance and regulations (e.g., Stark Law and Sunshine Act)
Proven expertise in payment logic creation and setup
Excellent understanding of payment reconciliation and analytics
Excellent written and verbal communication skills including relationship management skills with ability to drive achievement of objectives
Excellent problem-solving and critical thinking skills
Extensive understanding of clinical payments procedures while defining team operating standards and ensuring essential procedures are followed based on knowledge of own discipline
Ability to manage assigned team and/or provide training, coaching and/or feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
Proficient in Fair Market Value, EDC, CTMS
Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of clinical payments to the business
Knowledge of clinical research and operations acumen
Ability to manage confidential information with discretion
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including serving as consultant to management.
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
Ability to provide guidance to others on area of expertise
For California, the base pay range for this position is $118,000 to $160,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Req-38556
Full time
2 days ago
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
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