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.