FSP Site Budget & Contracts Specialist

Role Summary

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

Responsibilities

• Develop Clinical Trial Agreements (CTAs) using standard templates and information from Contract Information Sheets; ensure CTAs are executed timely to meet study start-up timelines; liaise with legal departments to ensure content changes are mutually agreeable and in line with client-approved standard language; participate in study kick-off meetings to obtain necessary information.
• Understand standard contract language to enable decision making on CTA sections when language modifications are proposed; coordinate with legal, sites, contractors or vendors to resolve non-compliant language.
• Generate site budgets based on final approved country budget; distribute to sites and follow up with investigators; research medical procedure costs to provide accurate data for site-level budgets.
• Manage CTAs ensuring changes are updated according to client legal standards and Global SOPs.
• Ensure annual review of all templates with Legal and Local Head of Monitoring and Site Management.
• Manage contract tracking database, coordinate timely updates related to CTAs, ensure accuracy, reconcile discrepancies, and post fully executed contracts in eFiliA and on the Clinical Operations drive.
• Process internal approval forms and other documents to ensure compliance with Internal Signatory Process and annual audits.
• Maintain excellent communication as the point of contact among clinical trial site personnel, client’s Head, Clinical Operations, Legal Counsel, and Manager, Insurance throughout contract negotiations.
• Prepare for internal audits by maintaining a complete paper trail for each site contract negotiation.
• Negotiate Master Services Agreements (MSAs) with institutions where clinical trials have been conducted and ensure they are reviewed prior to renewal dates.

Qualifications

• Education: Must have a Bachelor's degree or equivalent scientific or commercial higher education.
• Experience: Experience in healthcare, pharmaceutical industry, or clinical research preferred.

Skills

• Budgeting and financial analysis for clinical trials
• Contract negotiation and management
• CTAs and MSA familiarity
• Legal and regulatory document coordination
• Stakeholder management and cross-functional collaboration
• Strong written and verbal communication

Education

• Bachelor’s degree or equivalent

Additional Requirements

• Location: Home-based in USA or Canada
• Travel: Not specified; work is primarily home-based