ResponsibilitiesThe Clinical Research Finance Manager role is critical for sustaining research portfolios, often requiring a mix of financial acumen and operational knowledge of clinical workflows. Oversee the complete financial lifecycle of clinical trials and research grants, ensuring accuracy, compliance, and fiscal accountability across all study activities. This role leads budget development and sponsor negotiations, manages invoices and accounts receivable, and conducts ongoing financial monitoring and variance analysis.
Responsible for training and development of the research finance team members as well as the hiring, coaching, counseling, oversight and, performance reviews, termination, and the overall management of financial processes to support day-to-day activities. Responsible for pro-active policy and procedure development and revisions to meet industry standards.
The manager directs the Medicare Coverage Analysis process to support compliant billing and aligns financial operations with FDA, IRB, CMS, and institutional regulations. By partnering with investigators, study teams, and administrative leaders, this position ensures proper revenue recognition, supports study feasibility, and strengthens the financial integrity of the research portfolio. Ensures all financial processes, documentation standards, and operational workflows align with established research finance best practices across industry-sponsored research, investigator initiated and grant funded research.
Key Responsibilities- Budgeting & Contracting: Develop, negotiate, and finalize study budgets and clinical trial agreements (CTAs) with industry sponsors and Clinical Research Organizations (CROs).
- Invoicing & Revenue Management: Generate invoices for study startup, milestones, per-patient visits, and administrative fees. Reconcile payments and manage accounts receivable.
- Resource Management: Strong oversight of personnel and workload distribution, ensuring efficient allocation of staff time across core financial functions.
- Post-Award Management: Monitor study expenses, track project financial status against budgets, and process budget amendments.
- Compliance & Auditing: Ensure compliance with FDA regulations, ICH/GCP guidelines, and Medicare Coverage Analysis (MCA) to prevent billing errors.
- Reporting & Analysis: Prepare monthly, quarterly, and annual financial reports (budget vs. actual) for principal investigators and leadership.
- System Maintenance: Utilize Clinical Trial Management Systems (CTMS) and financial systems to set up study budgets, calendars, and track expenses.
Common Core Competencies- Strategic Planning: Forecasting financial performance to support organizational goals.
- Interpersonal Skills: Acting as a liaison between sponsors, researchers, and institutional finance teams.
- Problem-Solving: Identifying and resolving payment discrepancies and audit findings.
- Ensures timely and accurate financial information that is useful to management.
- Develops and implements monthly variance review processes.
Establish policies, procedures and programs, including technology and automation relative to the strategic and financial plan to ensure effective organizational accounting practices and procedures
QualificationsRequired Qualifications & Skills- Education: Bachelor's degree in finance, business, or a healthcare-related field.
- Experience: 3-5+ years in clinical research operations, finance, or accounting.
- Knowledge: Strong understanding of clinical trials, Medicare regulations, GAAP, and accounting principles.
- Software: Proficiency in Microsoft Excel, ERP systems (e.g., Oracle), and CTMS software.
