FSP Site Budget & Contracts Specialist

Role Summary

FSP Site Budget & Contracts Specialist. Home Based in USA or Canada. Must have 2+ years of budget/contract negotiation experience at CRO level with direct site facing experience. Responsible for preparing country site budgets and study financial appendices, assisting with the negotiation of site agreement budgets and financial exhibits of a certain complexity.

Responsibilities

• Develop Clinical Trial Agreements (CTAs) utilizing standard templates; ensure CTAs are executed in a timely manner to meet study start-up timelines. Liaise with legal to ensure content changes are mutually agreeable and in accordance with standard language; participate in study kick-off meetings to obtain necessary information.
• Understand standard contract language to enable decisions on CTA sections; resolve non-compliant language with legal, sites, contractors, or vendors.
• Generate site budgets based on final country budget; distribute to sites and follow up with investigators. Research costs using databases to provide accurate data for site budgets.
• Manage CTAs ensuring changes are updated per legal standards and Global SOPs.
• Ensure annual review of templates with Legal and Local Head of Monitoring and Site Management.
• Manage contract tracking database, coordinate updates, post executed contracts in eFiliA and secure drives.
• Process internal approval forms and documents to ensure compliance with Internal Signatory Process and audits.
• Maintain communication as point person among trial site personnel, client’s Head, Clinical Operations, Legal Counsel, and Manager, Insurance during contract negotiations.
• Prepare for internal audits by maintaining a complete paper trail for each site contract negotiation.
• Negotiate Master Services Agreements (MSAs) with Institutions and ensure review prior to renewal dates.

Qualifications

• Education: Must have a Bachelor’s degree or equivalent scientific or commercial Higher Vocational education.
• Experience: 2+ years in budget/contract negotiation for CROs; healthcare/pharma/clinical research experience preferred.

Skills

• Contract negotiation
• Budget development and financial analysis
• CTA management
• Document control and regulatory compliance
• Stakeholder communication
• Legal coordination and cross-functional collaboration

Education

• Bachelor’s degree or equivalent

Additional Requirements

• Physical requirements: Standard office environment; occasional lifting up to 15-20 lbs may be required.
• Work environment: Home-based or office-based; travel not specified.