Clinical Budgets Analyst

Clinical Budgets Analyst

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 under-treated. 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.

As the Clinical Budgets Analyst, you will negotiate and develop site budgets for clinical trials, ensure all budgets align with regulatory and fair market value guidelines, and manage the full budget lifecycle from study start-up through close-out.

This is a hybrid role (office and remote blend). Selected candidate must reside within a reasonable distance from the Irvine corporate location and have the ability to commute on required onsite days.

How you'll make an impact:

• Initiate, draft and negotiate moderately complex clinical trial budgets based on substantial knowledge of financial/fair market value, CPT codes as it relates to the approved protocols.
• Identify financial risks and actively engage with management to provide recommendations for mitigation on budget negotiations. Provide clinical input on budget terms and scope of services to secure appropriate approvals in collaboration with key stakeholders (e.g. Site Payment Teams, Study Teams).
• Analyze need for contract amendments or renewals and make recommendations, and/or negotiate changes.
• Identify risk associated with project timelines set by project teams, impacting team's deliverables and timelines, and key stakeholders' workload (e.g., Legal Compliance Study Teams).
• Other duties may be assigned by leadership.

What you'll need (Required):

• Bachelor's Degree in related field with 3 years of previous related experience in budget development and negotiations in the Healthcare industry, or equivalent work experience based on Edward's criteria.

What else we look for (Preferred):

• 3 years of solid experience working with CPT codes, including selecting the appropriate codes based on required procedures outlined in clinical trial protocols.
• Experience with Fair Market Value (FMV) platforms.
• Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, Excel, and SharePoint.
• Extensive knowledge and understanding of Edwards policies, procedures, and guidelines relevant to budget negotiation and administration.
• Extensive understanding of clinical trial protocols, Schedules of Assessment, trial design, and CPT coding necessary to develop accurate and compliant clinical trial budgets
• Develop and create a budget using an approved trial protocol.
• Collaborate with the trial team and clinical Project Manager to strategize on site prioritization and enable fast site activation.
• Partner with Clinical Contracts Management to align on negotiation timelines and effectively plan for final contract execution dates.
• Follow the budget negotiation process to enable fast budget negotiation and plan for the budget execution.
• Initiate, draft, redline, and negotiate moderately complex payment and budget terms for invoiceable budget line items and trial costs to support the internal Site Payment teams as well as the trial Team on trial costs and payments.
• Collaborate with the Site Payments Team to respond to invoice inquiries from the Sites to find the appropriate resolution.
• Actively engage with management to provide recommendations for budgetary escalation that is above and beyond the Fair Market Value (FMV).
• Provide input on CPT codes during the creation of a new budget template for a trial or during a budget template modification.
• Work with the Compliance Partner to send in the FMV template for each trial and identify any discrepancies or cost above FMV to ensure compliance with applicable regulations and procedures.
• Analyze need for contract amendments due to major budget impacts because of Protocol or trial changes, aligning with internal work instructions and practices; make recommendations for budget modifications based on protocol changes.
• Identify risks associated with project timelines set by project teams, impacting team's deliverables and timelines, and key stakeholders' workload (e.g., Legal Compliance) based on revised timelines
• Identify opportunities for process improvement independently or in partnership with cross-functional teams, and present and implement improvement plans to management and key stakeholders.
• Ability to collaborate with internal stakeholders (Site Payments Team) to reconcile contractual payment obligation to the budget that is in the SOW
• Strong attention to detail and the ability to build and maintain effective internal and external working relationships.
• Ability to interact professionally with all organizational levels.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $68,000 to $90,000 (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.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

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.