Associate Director, Clinical Trial Budget Planning & Management

Role Overview

The Associate Director, Clinical Trial Budget Planning & Management is responsible for enabling the planning, forecasting, tracking, analysis, and financial oversight of clinical operations budgets across the portfolio. This individual will serve as a partner to Clinical Operations Program Leads and Finance to enable accurate trial budget forecasting, vendor budget assessments for cost efficiency, and financial transparency throughout the lifecycle of clinical trials.

Key Responsibilities

Clinical Trial Budget Planning & Forecasting

• Collaborate with study Operations Program Leads (OPLs) for development of annual operating budgets, long-range plans, and quarterly forecasts for clinical trial budgets.
• Partner with Clinical Operations and Finance to develop activity-based budget assumptions reflecting efficient labor requirements from vendors (CROs) to support enrollment timelines, site activations, and site monitoring and management strategies.
• Build and maintain detailed trial-level and program-level budget models incorporating planned expenditures, and anticipated timing of spend.
• Develop multi-year forecasts and scenario analyses to support portfolio planning and strategic decision making.
• Evaluate budget impacts associated with protocol amendments, study expansions, country additions, enrollment changes, and vendor scope modifications.
• Support vendor engagement strategy discussions through financial analyses and budget recommendations.

Financial Tracking, Governance & Performance Management

• Maintain visibility into actual spend, committed spend, accruals, and forecasted expenditures across multiple clinical programs.
• Monitor purchase orders, invoices, contract commitments, milestone payments, and activities impacting accrual calculations.
• Perform regular budget reviews and variance analyses to identify key drivers of financial performance.
• Reconcile differences between Finance reports and operational budget tracking systems.
• Develop spending trend analyses and provide proactive identification of financial risks and opportunities.
• Ensure budget assumptions are updated as needed based on actual spend analysis from ongoing programs.

Cross-Functional Partnership

• Serve as a primary financial business partner for Clinical Operations and Finance.
• Collaborate closely with Finance to support forecasting cycles, accrual reviews, and budget submissions.
• Facilitate budget planning meetings to align assumptions and timelines.
• Gather budget inputs from OPLs and consolidate information into comprehensive forecast packages.
• Provide early visibility of significant expenditures, budget risks, and high-value commitments to OPL contacts.
• Support OPL decision making through financial insights and scenario modeling.

Vendor & Contract Financial Oversight

• Partner with Vendor Management, Legal, Procurement, and Clinical Operations to ensure alignment between study budgets, contract obligations, and planned expenditures.
• Monitor vendor financial performance against approved budgets.
• Track contract milestones and anticipated expenditures across current and future fiscal years.
• Identify financial risks associated with scope changes, enrollment fluctuations, and contract amendments.
• Support budget negotiations and financial evaluations of vendor proposals when required.

Reporting & Business Analytics

• Generate monthly, quarterly, and annual budget reports for OPLs.
• Create dashboards and visualizations (as needed) to communicate portfolio financial performance and forecast accuracy.
• Analyze historical spending patterns to improve future planning assumptions.
• Establish and monitor key performance indicators related to budget predictability, forecast accuracy, and spend efficiency.