Clinical Site Contract Specialist

2 settimane fa

Roma, Lazio, Italia 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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