Contract Specialist II, Site Agreement / Contract & Budget Specialist - FSP Team - Italy

The Site Budget & Contracts Specialist is responsible for drafting, negotiating, and managing site agreements and related clinical trial contracts for Sponsor-led studies. The role ensures timely execution of agreements, compliance with SOPs and ICH-GCP principles, and close collaboration with cross‑functional clinical study teams.

Key Responsibilities

• Draft, review, negotiate, and process site agreements, templates, and related clinical trial contracts in accordance with Fortrea policies and Sponsor requirements.
• Manage the full contract lifecycle, including tracking, approvals, execution, filing, and status updates using SAMS or equivalent systems.
• Independently manage assigned studies while ensuring strict adherence to SOPs, quality standards, and regulatory requirements.
• Identify contractual risks or operational delays early and escalate issues proactively to ensure timely resolution.
• Coordinate with clinical study teams, project management, business development, and budget teams to align contract timelines and expectations.
• Provide regular and accurate contract status updates to management and internal stakeholders.
• Contribute to departmental objectives, process improvements, and support junior colleagues as required.

Experience & Qualifications

• 3 - 5 years’ experience in clinical contracts, site agreements, or contract administration within a CRO or pharmaceutical environment.
• Demonstrated experience in contract drafting, negotiation, and lifecycle management.
• Solid knowledge of ICH-GCP, SOP-driven environments, and clinical trial regulations.
• Bachelor’s degree preferred (Law, Business, or Life Sciences); law degree (EU) is an advantage.
• Strong organizational skills with the ability to manage multiple studies simultaneously.

This is an excellent opportunity to contribute to global clinical studies while further developing your clinical contracts expertise within a dynamic CRO environment.

Learn more about our EEO & Accommodations request here.