Contract and Budget Specialist

nd 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.

Core Responsibilities
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. Contract Review & Management (Clinical Trial Agreements)
• 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
• Ensure payment milestones align with:
• Visit schedules
• Deliverables
• Contractual obligations
• Support Finance and Operations with:
• Invoice readiness
• Payment reconciliation
• Identification of missed or delayed payments
• Track budget vs. actual performance
• Flag revenue leakage risks and under-billing trends

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
• Ensure amendments are executed prior to implementation of new scope
• Track amendment approval and execution timelines

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

Authority & Decision-Making
• 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

Required Qualifications
• 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

Preferred Skills & Competencies
• 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