Clinical Program & Financial Operations Manager (Clinical Trials)

Here’s a refined role that better reflects your emphasis on budget control + clinical execution : Job Title: Clinical Program & Financial Operations Manager (Clinical Trials) Position Summary The Clinical Program & Financial Operations Manager is responsible for end-to-end oversight of clinical trial execution with a primary focus on budget planning, cost tracking, variance analysis, and financial governance . This role integrates traditional clinical project management with rigorous financial oversight to ensure trials are delivered on time, within scope, and within budget . This position serves as the critical interface between Clinical Operations, Finance, CROs, and executive leadership, providing real-time visibility into trial spend and forecasting accuracy . Key Responsibilities 1. Clinical Trial Financial Management (Primary Focus)
Develop and maintain detailed clinical trial budgets (CRO, sites, vendors, central labs, imaging, drug supply, etc.)
Track actual spend vs. budget vs. forecast at a granular level (per patient, per site, per activity)
Perform variance analysis and identify cost drivers (e.g., enrollment delays, protocol amendments, screen failure rates)
Build and manage rolling forecasts and scenario-based financial models
Review and reconcile CRO/vendor invoices against contracts and work performed
Ensure alignment between contracted scope (SOW) and billed activities
Support accruals, financial close processes, and audit readiness 2. Vendor & CRO Financial Oversight
Lead budget negotiations with CROs and vendors
Evaluate proposals and ensure cost competitiveness across vendors (e.g., OCT, CROMOS, GCT comparisons)
Monitor CRO performance against financial KPIs (cost per patient, monitoring frequency, pass-through costs)
Identify opportunities for cost optimization without compromising quality 3. Clinical Operations Support
Partner with Clinical Operations to ensure trial milestones align with financial plans
Track enrollment metrics and correlate with budget burn rates
Support feasibility assessments with cost modeling (e.g., country/site selection impact on budget)
Assist in planning for protocol amendments and their financial implications 4. Reporting & Executive Communication
Develop dashboards and reports for leadership:
Budget vs. actual vs. forecast
Cost per enrolled/randomized patient
Site-level spend and productivity
Provide clear, investor-ready financial narratives for clinical programs
Support Board, investor, and regulatory reporting as needed 5. Contract & Risk Management
Review and manage contracts (MSA, SOW, site agreements) with focus on financial terms
Identify financial risks (e.g., enrollment shortfalls, currency fluctuations, scope creep)
Implement controls to prevent budget overruns
Ensure compliance with internal policies and external regulations 6. Strategic Planning
Support portfolio-level budgeting across multiple programs (e.g., Sapu003, Sapu006, OT-101)
Contribute to clinical development strategy with financial modeling inputs
Assist in preparation for financing, partnerships, and IPO readiness by providing cost transparency Qualifications Education & Experience
Bachelor’s degree in Life Sciences, Finance, or related field (MBA or advanced degree preferred)
5–10+ years in clinical trial management, clinical finance, or CRO/vendor management
Experience managing budgets for Phase 1–3 clinical trials Technical Skills
Strong expertise in:
Clinical trial budgeting tools (e.g., Excel advanced modeling, CTMS, ERP systems)
Financial analysis and forecasting
Contract and invoice review
Familiarity with clinical trial processes (GCP, ICH guidelines) Core Competencies
Exceptional analytical and financial modeling skills
Ability to translate complex financial data into actionable insights
Strong negotiation and vendor management capabilities
High attention to detail and audit readiness mindset
Cross-functional leadership and communication skills Preferred Experience
Experience working with or managing CROs in global trials (US + Europe)
Exposure to oncology trials (e.g., mTOR inhibitors, taxanes, biomarker-driven studies)
Experience in small biotech or fast-scaling environments
Familiarity with per-patient costing models and enrollment-driven budgeting Key Performance Indicators (KPIs)
Budget adherence (% variance from plan)
Forecast accuracy
Cost per patient vs. benchmark
Invoice accuracy and cycle time
CRO/vendor financial performance
Identification and realization of cost savings