Clinical Research Budget and Billing Program Manager
University of Virginia · Charlottesville, VA · 2 wk ago
AnalystFull-time
About the role
The Clinical Research Budget and Billing Program Manager will lead UVA’s clinical research budgeting and billing program to ensure compliant, efficient, and financially sound clinical trial operations.
Responsibilities
- Lead the clinical research budgeting and billing program, providing oversight, education, and support across UVA.
- Maintain expertise in applicable regulations, including CMS and FDA requirements, Medicare coverage rules, Federal Anti-Kickback laws, HIPAA, and institutional policies.
- Perform and oversee coverage analyses to determine appropriate billing of protocol-required services to sponsors, research accounts, third-party payers, or other sources.
- Develop and negotiate clinical trial budgets for industry-sponsored trials, grants, and consortium studies. Ensure budgets capture personnel effort, clinical procedures, non-procedural costs, institutional fees, and invoiceable services.
- Serve as a primary contact for pharmaceutical companies, biotechnology companies, and CROs, in partnership with CTU leadership. Assess incoming study opportunities and help match protocols with appropriate Principal Investigators based on expertise, interest, patient population, and research capacity.
- Manage and support staff responsible for research billing, including coverage analysis and second-pass review of study-related charges in Epic. Ensure charges follow the approved coverage analysis and applicable regulations and policies.
- Oversee OnCore calendar and financial console builds to support study financial management, invoicing, and cost recovery. Train study teams to use these tools effectively.
- Manage sponsor invoicing processes to ensure accurate and timely invoicing when contractual milestones are met.
- Maintain an assigned study portfolio and provide backup support for budgeting, coverage analysis, billing, and invoicing when needed.
- Conduct research billing audits to identify compliance or operational gaps. Develop and implement corrective actions at the study, departmental, and institutional levels.
- Develop and deliver training for investigators and research staff on clinical research budgeting, billing, coverage analysis, and financial processes.
- Develop and maintain a clinical research charge master for non-medical research services.
- Develop and monitor performance metrics for trial activation, budgeting, billing, invoicing, CTU utilization, staff effort, cost recovery, and financial performance.
- Drive continuous improvement by identifying inefficiencies, standardizing processes, and implementing solutions that improve compliance, turn