Site Budget Management

About the role

The Site Budget Management Office (SBMO) Clinical Budget Manager serves as a subject matter expert in the development of global clinical trial budgets. This role partners closely with R&D, Purchasing, Finance, Legal, Clinical Payments, and Site Management teams to create robust, transparent, and compliant clinical site budgets.

Responsibilities

• Provide operational expertise, leadership, and support to cross-functional teams on all aspects of clinical budget development and management, including study forecast estimates using limited inputs.
• Build bottom-up and top-down forecast models by month across all phases of the study lifecycle, ensuring accuracy and alignment with overall project projections.
• Identify key financial risk drivers such as enrollment velocity, screen failure rates, protocol amendments, country mix, and complexity factors, and incorporate these into forecasting and planning.
• Deliver monthly forecast updates and detailed variance analyses, explaining drivers of change and recommending corrective actions where needed.
• Escalate financial risks that may impact study timelines, budget integrity, or broader program objectives to appropriate stakeholders in a timely manner.
• Develop, negotiate, and coordinate transparent clinical trial budgets for both large and small sites in line with industry standards, and analyze existing budgets to identify cost drivers and optimization opportunities.
• Partner with R&D and other stakeholders to build global clinical site budgets that comply with all applicable policies, procedures, and corporate objectives.
• Assist in the management and coordination of Sponsor and CRO clinical budget analyst staff, providing guidance and oversight on budget-related activities.
• Develop and maintain global budget development documents, including Exhibit A and other Fair Market Value tool assessments, ensuring consistency and audit readiness.
• Align negotiation parameters (high, mid, and low ranges) with SBMO processes to support standardized and fair budget negotiations.
• Review research protocols, protocol synopses, and related documents to support budget development and identify key cost drivers, particularly for complex or unique protocols.
• Serve as the first line of contact to internal stakeholders to provide insight into the clinical budget development process for challenging protocols, including those with underrepresented participant populations or high complexity.
• Create global and country-specific clinical trial budget templates and Fair Market Value benchmarks using clinical budgeting tools and systems such as ClearTrial, MediDate, Conga, SharePoint, and similar platforms, and lead subsequent budget negotiations.
• Update key internal and external stakeholders on budget creation status, highlighting progress, risks, and issues that could impact project timelines or study start-up.
• Analyze existing budgets to identify cost drivers, trends, and outliers, and recommend adjustments to improve financial performance and budget accuracy.
• Identify quality improvement opportunities to streamline and enhance processes related to budget development, negotiation, and associated services.
• Apply and interpret United States Medicare Coverage Analysis (MCA) guidelines for applicable therapeutic areas, ensuring appropriate allocation of costs.
• Collaborate closely with Clinical Management leadership, Study Project Managers, Clinical Trial Associates, Therapeutic Area leads, Legal, outside-US stakeholders, Contracts Managers, and Clinical Payments teams to ensure cohesive and efficient budget management.

Requirements

• Minimum of 5 years of experience in the management and independent development of clinical trial budgets.
• Demonstrated experience with global clinical budgets, including regions such as the United States, Canada, European Union, United Kingdom, and Australia.
• Strong budgeting, forecasting, and financial analysis skills, with the ability to build and interpret complex financial models.
• Advanced proficiency in Microsoft Excel for data analysis, modeling, and reporting.
• Expertise in Fair Market Value analysis and use of FMV benchmarking tools.
• Familiarity with regulatory requirements and guidelines for clinical trials, including FDA regulations and ICH GCP guidelines.
• Excellent organizational and time management skills, with the ability to prioritize tasks and manage multiple projects effectively.
• Strong interpersonal and communication skills, with the ability to collaborate effectively in a cross-functional team environment.
• Ability to maintain confidentiality and handle sensitive financial and clinical information appropriately.

Essential Skills

• BA/BS degree is required, with a degree in Science or Finance preferred.
• Experience working with clinical budgeting tools and systems such as ClearTrial, MediDate, Conga, SharePoint, or similar platforms.
• Understanding and practical application of United States Medicare Coverage Analysis (MCA) guidelines in relevant therapeutic areas.
• Demonstrated ability to identify process improvement opportunities and contribute to the enhancement of budget-related workflows.
• Willingness and ability to travel up to approximately 15% of the time, as required by project needs.