Clinical Site Contract Specialist

6-Month Contract | 0.5 FTE (Part-Time)
Europe (Italy & UK Focus)

About the Role

We are seeking an experienced Clinical Site Contract Specialist to support contract and budget negotiations for clinical trial sites across Italy and the UK. This part-time role involves direct responsibility for preparing, negotiating, and finalising Clinical Trial Agreements (CTAs) and associated budgets for studies ranging from Phase I to Phase IV.

The ideal candidate has hands-on experience with clinical site contracts within a CRO or pharmaceutical environment, a strong understanding of regional regulatory and operational requirements, and the ability to work independently while partnering effectively with cross-functional teams.

Key Responsibilities

• Lead the negotiation and finalisation of Clinical Trial Agreements and budgets for industry-sponsored clinical trials (Phase I-IV) in Italy and the UK.

• Serve as a subject matter expert for contract and budget negotiations with Spanish sites.

• Collaborate closely with the Senior Contract Manager to define timelines, contracting strategies, and deliverables across multiple EU studies.

• Maintain proactive communication with clinical sites to gather updates, resolve questions, and support smooth negotiation processes.

• Identify, report, and escalate contracting issues in accordance with timelines, study plans, SOPs, and guidance from the Senior Contract Manager.

• Track progress across assigned contracts and budgets using study-specific tools; maintain up-to-date weekly trackers for ongoing studies.

• Support the preparation of country-specific templates and budgets.

• Provide translation support (Italian ↔ English) when required.

• Review and tailor budgets, agreements, and amendments based on study protocols and standard templates for Italy and the UK.

• Build and maintain strong working relationships with clinical sites and internal study teams; attend internal or sponsor meetings as required.

• Work autonomously on contract and budget negotiations within assigned regions.

Requirements

Education

• Degree in Life Sciences or Law, or equivalent experience within clinical research contracting.

Experience

• 2-3 years' experience negotiating site budgets and contracts within the EU and UK.

• Previous experience within a CRO or pharmaceutical company required.

• Background in clinical site contracting or paralegal work strongly preferred.

• Direct experience negotiating contracts in Italy is a significant advantage.

• Experience managing pricing or third-party vendor contracting is beneficial.

• CRA backgrounds are not preferred for this role.