Clinical Site Contract Specialist

1 settimana fa

Rome Latium Italy, IT SEC Life Sciences A tempo pieno

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.

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