Pre-Award Budget And Financial Analyst The Pre-Award Budget and Financial Analyst is a critical role within the Protocol Activation and Lifecycle Management (PALM) team, responsible for completing assigned Medicare Coverage Analyses (MCAs) and research budgets. This includes developing, reviewing, and negotiating clinical trial and research study budgets with external research sponsors and stakeholders in alignment with the completed study MCA. This role ensures that all assigned MCAs and budgets are accurate, compliant, and financially viable. The position works closely with investigators, study teams, sponsors, Clinical Research Organizations (CROs), legal teams, and other internal stakeholders to align financial terms with study requirements, billing compliance, and institutional policies.
Key Responsibilities:
Qualified Clinical Trial Evaluation (QCT) and Medicare Coverage Analysis (MCA):Conduct thorough evaluations to determine which studies qualify under Medicare guidelines and institutional policies, and document results in the Clinical Trial Management System (CTMS), OnCore. Completion of Coverage Analysis and/or review of third-party vendor-completed Coverage Analysis, ensuring adherence to all applicable national and local coverage determinations, Medicare policies, and other relevant guidance. Apply deep understanding of Medicare benefit categories and other study factors that may impact qualifying status (e.g., compassionate use, comparative effectiveness, coverage with evidence development, etc.).Budget Development & Financial Analysis Provide professional support and assistance to faculty and administrators seeking external funding for research and other sponsored projects. Develop, review, and manage comprehensive clinical trial budgets for industry-sponsored, investigator-initiated, and federally funded studies. Collaborate with investigators, study coordinators, department administrators, and central offices to support timely study start-up. Review sponsor documents (i.e., applications, award notices, research protocols, and terms and conditions). Perform detailed cost analyses, including per-patient costs, pass-through expenses, start-up fees, and overhead. Ensure budgets align with study protocols, schedules of events, MCAs and institutional policies. Conduct financial feasibility assessments for new, incoming study opportunities.
Budget Negotiation:
Lead budget negotiations with sponsors, CROs, and other external partners to ensure full cost recovery and alignment with institutional standards.
Collaborate closely with internal legal and contracts teams to align budget terms with clinical trial agreements.
Negotiate payment schedules, milestone payments, invoice terms, and reimbursement structures in collaboration with internal legal representatives.
Negotiate budget amendments and resolve budget-related issues and discrepancies throughout the study lifecycle.
Well-represent Yale and Yale professional standards during all communications, internally and externally.
Compliance & Process Improvement:
Ensure compliance with Federal, State, Local, and institutional policies.
Maintain accurate financial documentation and audit-ready records.
Contribute to the development and improvement of MCA and budgeting tools, templates, and standard operating procedures to enhance pre-award financial workflows and efficiency.
Stay current with industry trends, sponsor pricing models, and regulatory changes affecting clinical trial finance.
Investigate issues, evaluate the full context, and identify policies, procedures, and guidance to support resolution. Propose recommendations or solutions as appropriate.
Collaborate with other Business Offices, Central Offices, external institutions and sponsoring agencies to ensure the proper management of sponsor funds.
Required Skills and Abilities:
Experience in clinical research budgeting, coverage analysis, billing and/or a related area. Demonstrated experience developing detailed Medicare Coverage Analyses and clinical research budgets, with strong knowledge of the respective guiding polices and regulations. Demonstrated experience negotiating clinical trial budgets with sponsors or CROs and/or negotiating clinical trial budgets with research sites on behalf of sponsor/CRO.Effective project management skills, with the ability to handle multiple projects simultaneously, independently problem-solve, and effectively manage time workload. Excellent communication, negotiation, problem-solving, critical thinking, and stakeholder management skills. Ability to prioritize and adapt in a fast-paced, remote work environment. Proficient technology skills, including Microsoft Office Suite, use of Clinical Trial Management Systems and Electronic Medical Record systems. Ability to leverage and interpret data.
Preferred Skills and Abilities:
Master's degree in a related field.
Professional certification (e.g., CCRA, CCRP, or financial certifications).Experience in academic medical centers, CROs, and/or pharmaceutical/biotech organizations.
Knowledge of clinical trial contracts, billing compliance, and charge review processes.
Direct experience with OnCore CTMS, Epic EMR and Salesforce CRM.
