FSP Site Budget & Contracts Specialist

Role Summary

FSP Site Budget & Contracts Specialist. Home based in USA or Canada. Requires 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 and assisting with the negotiation of site agreement budgets and financial exhibits of a certain complexity.

Responsibilities

• Develop Clinical Trial Agreements (CTAs) utilizing standard templates and information from Contract Information Sheets. Ensure CTAs are executed in a timely manner to meet study start-up timelines. Liaise with legal departments to ensure content changes to CTAs are mutually agreeable and in accordance with client-approved standard language. Participate in Study kick-off meetings to obtain necessary information for CTA execution.
• Understand standard contract language to enable decision-making on CTA sections when language modifications are proposed by external parties; if non-compliant, discuss with legal and coordinate with legal, sites, contractors or vendors to resolve.
• Generate site budgets based on final approved country budget for distribution to sites and follow up with investigators. Research medical procedure costs using local/global databases to provide data for site budgets, enabling Country Lead Monitors/Study Managers to calculate latest average costs for procedures.
• Manage CTAs ensuring changes to agreements and components are updated per client 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 for CTAs, reconcile discrepancies, and post fully executed contracts in eFiliA and local secure drive.
• Process study-specific internal approval forms and other documents to ensure compliance with Internal Signatory Process and annual audits.
• Maintain excellent communication and collaboration as the point of contact among clinical trial site personnel, client’s Head, Clinical Operations, Legal Counsel, and Manager, Insurance throughout the contract negotiation process.
• Prepare for internal audits by maintaining a complete and accurate 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 Vocational education.
• Experience: 2+ years in budget/contract negotiation at CRO level with direct site-facing experience; experience in healthcare, pharmaceutical industry, or clinical research preferred.

Skills

• Contract negotiation
• Budget preparation and financial modeling for clinical trials
• Legal and regulatory alignment of CTAs
• Documentation control and audit readiness
• Stakeholder management and cross-functional collaboration

Additional Requirements

• Location: Home-based in the USA or Canada
• Travel: Not specified