Responsibilities:
- Take ownership of assigned CTA and budget amendments, including requests already in negotiation.
- Review the current agreement, budget, and sponsor or CRO correspondence to identify open issues and next steps.
- Compare revised protocols and visit schedules against the executed budget.
- Identify added or changed visits, procedures, screening requirements, cohorts, and extension phases that need to be priced.
- Draft and redline CTA amendments and budget exhibits.
- Build Excel counterproposals covering per-visit costs, invoiceable items, screen failures, pass-through costs, and site overhead.
- Negotiate directly with sponsor and CRO contacts on rates and payment terms, including holdbacks, invoicing timelines, and payment for work sites have already performed.
- Work with site teams and Finance to verify what was performed, what can be invoiced, and what remains outstanding.
- Hand off executed amendments with the updated budget, effective dates, and any retroactive billing terms.
- Track status, deadlines, and document versions through signature.
- Flag recurring budget gaps.
- Escalate legal issues such as indemnification, subject injury, and intellectual property to leadership or counsel.
Required Experience:
- At least three years of experience negotiating clinical trial agreements and budgets, including direct responsibility for drafting, redlining, and negotiating CTA and budget amendments for U.S. studies.
- Experience at a research site, site network, site management organization, research institution, or CRO.
- Ability to independently translate a protocol amendment into a revised site budget and explain the basis for a counterproposal.
- Strong working knowledge of U.S. site budgets and payment terms, including per-visit costs, invoiceables, pass-throughs, overhead, and payment schedules.
- Proficiency with Microsoft Word Track Changes and Excel, plus strong written and spoken English for direct negotiations with sponsors and CROs.
- Ability to manage 20 or more concurrent amendments, prioritize issues that affect site payments, and follow up independently.
