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. Apply tot his job Apply To this Job