Budget Specialist

Position Overview

The Contract and Budget Specialist is responsible for the development, review, negotiation support, execution tracking, and financial governance of all clinical trial budgets, clinical trial agreements (CTAs), amendments, and payment schedules
.

This role ensures that all studies are financially viable, contractually compliant, accurately budgeted, and properly executed
, while protecting the organization from financial leakage, scope creep, and contractual risk
.

The role serves as a key interface between Sponsors/CROs, Clinical Operations, Finance, and Leadership
, and is a core contributor to study feasibility, startup efficiency, revenue integrity, and audit readiness
.

• 1. Study Budget Development & Financial Modeling
  • Develop and maintain study-level budgets
    , including:
    • Per‑visit costs
    • Start‑up fees
    • Screen failure assumptions
    • Pass‑through costs
    • Pharmacy, lab, and vendor costs
    • Overhead and indirect cost allocations
  • Ensure budgets reflect:
    • Protocol complexity
    • Site capacity and operational burden
    • Historical performance data
  • Partner with Clinical Operations and Feasibility teams to validate cost assumptions
  • Support budget re‑forecasting following protocol amendments or scope changes
• 2
  
  IFICATIONS
  • Coordinate and support review of:
    • Clinical Trial Agreements (CTAs)
    • Budget exhibits
    • Payment schedules
    • Amendments and change orders
  • Ensure alignment between:
    • Contract language
    • Budget terms
    • Operational execution
  • Track contract status from initial draft through execution
  • Maintain contract version control and execution timelines
• 3. Budget & Contract Negotiation Support
  • Support Sponsor and CRO negotiations related to:
    • Budget line items
    • Payment milestones
    • Invoice triggers
    • Pass‑through reimbursement terms
  • Prepare negotiation summaries and financial justifications
  • Escalate non‑standard or high‑risk terms to leadership
  • Ensure approved negotiation outcomes are reflected in final contracts and budgets
• 4. Payment Milestones, Invoicing & Revenue Integrity
  ...
• 5. Amendments, Change Orders & Scope Control
  • Assess financial and contractual impact of:
    • Protocol amendments
    • Enrollment changes
    • Visit schedule changes
    • Added procedures or assessments
  • Prepare revised budgets and amendment exhibits
• 6. Compliance, Audit & Documentation Support
  • Maintain inspection‑ready documentation for:
    • Executed contracts
    • Budget approvals
    • Amendment history
  • Support:
    • Sponsor audits
    • Internal audits
    • Financial reviews
  • Ensure documentation accuracy, traceability, and version control
  • Support CAPAs related to contract or budget deficiencies
• 7. Cross‑Functional Collaboration
  • Collaborate closely with:
    • Clinical Operations
    • Feasibility
    • Finance
    • Legal / External Counsel
    • Executive Leadership
  • Serve as a central point of coordination for budget and contract‑related inquiries
  • Support leadership with financial summaries and decision support
• 8. Metrics, Reporting & Continuous Improvement
  • Track and report on:
    • Budget cycle times
    • Contract execution timelines
    • Amendment frequency
    • Payment delays
  • Identify trends impacting:
    • Startup timelines
    • Revenue realization
    • Sponsor performance
  • Recommend process improvements to enhance efficiency and financial control

• Authorized to:
  • Draft and revise study budgets
  • Recommend acceptance or rejection of financial terms
  • Escalate unfavorable or non‑compliant contract terms
• May delay study activation when:
  • Budgets are not finalized
  • Contracts are not fully executed
  • Financial risk is unresolved
• Acts as an audit‑facing role for contract and budget documentation

• Bachelor’s degree in Finance, Business, Healthcare Administration, or related field (preferred)
• 2–5 years experience in:
  • Clinical research budgeting
  • Contracts administration
  • Finance or business operations
• Strong understanding of:
  • Clinical trial cost structures
  • CTA components
  • Sponsor/CRO contracting models
• Experience supporting audits or financial reviews

• Strong analytical and financial modeling skills
• Ability to manage multiple studies and deadlines simultaneously
• Effective communication and negotiation support skills
• Strong understanding of clinical trial operations