Clinical Site Contract Specialist

1 settimana fa

Roma, Lazio, Italia SEC Life Sciences A tempo pieno 40.000 € - 80.000 € all'ano

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.

  • Site Relationship Manager

    2 giorni fa

    Roma, Lazio, Italia TFS HealthScience A tempo pieno 40.000 € - 80.000 € all'ano

    About this roleTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions.The Site Relationship Manager (SRM) covers...

  • Robotics Clinical Specialist

    1 settimana fa

    Roma, Lazio, Italia MEDICAL-NOTE A tempo pieno 60.000 € - 80.000 € all'ano

    MEDICAL-NOTE è un azienda che fornisce Capital Equipment e servizi digitali per il mondo della Chirurgia e della Medicina in generale. Da settembre 2024 è distributrice della Piattaforma robotica Toumai prodotta da Microport Medbot.Per il potenziamento del nostro team Robotics cerchiamo un Robotics Clinical SpecialistLa persona che ricoprirà il ruolo di...

  • Clinical Research Associate

    1 settimana fa

    Roma, Lazio, Italia Parexel A tempo pieno 60.000 € - 80.000 € all'ano

    Parexel FSP is hiring for two experienced CRA's at either the CRA II or Senior CRA level to join one of a large Sponsor's in the EU.This role is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study executionSome specifics about this advertised roleEnsure...

  • Clinical Project Manager

    2 giorni fa

    Roma, Lazio, Italia IQVIA A tempo pieno 60.000 € - 120.000 € all'ano

    The IQVIA Clinical Functional Service Partnerships (Clinical FSP) department is providing highly skilled professionals to our client's project team to set-up and execute clinical trials. Joining the sponsor-dedicated team provides the opportunity to work with clinical research projects in different therapeutic areas.Clinical Project Managers are an integral...

  • Clinical Project Manager

    4 giorni fa

    Roma, Lazio, Italia IQVIA A tempo pieno 60.000 € - 80.000 € all'ano

    The IQVIA Clinical Functional Service Partnerships (Clinical FSP) department is providing highly skilled professionals to our client's project team to set-up and execute clinical trials. Joining the sponsor-dedicated team provides the opportunity to work with clinical research projects in different therapeutic areas.Clinical Project Managers are an...

  • Clinical Project Manager

    4 giorni fa

    Roma, Lazio, Italia IQVIA A tempo pieno 40.000 € - 80.000 € all'ano

    The IQVIA Clinical Functional Service Partnerships (Clinical FSP) department is providing highly skilled professionals to our client's project team to set-up and execute clinical trials. Joining the sponsor-dedicated team provides the opportunity to work with clinical research projects in different therapeutic areas.Clinical Project Managers are an...

  • Clinical Project Manager

    1 settimana fa

    Roma, Lazio, Italia TFS HealthScience A tempo pieno 80.000 € - 120.000 € all'ano

     TFSHealthScience is a leading global, mid-size Contract Research Organization(CRO) that partners with biotechnology and pharmaceutical companies throughouttheir entire clinical development journey. Our expertise includes fullservice-capabilities, resourcing and functional service (FSP) solutions.About this roleThe Project Manager has the overall...

  • Clinical Project Manager

    4 giorni fa

    Roma, Lazio, Italia TFS A tempo pieno 42.000 € - 75.000 € all'ano

    TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.About this roleThe Project Manager has the overall...

  • Clinical Safety Specialist

    1 settimana fa

    Roma, Lazio, Italia Medtronic A tempo pieno 60.000 € - 120.000 € all'ano

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeAs a Clinical Safety Specialist, you will play a key role in ensuring the highest standards of safety...

  • Clinical Safety Specialist

    1 settimana fa

    Roma, Lazio, Italia Medtronic A tempo pieno 40.000 € - 80.000 € all'ano

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeAs a Clinical Safety Specialist, you will play a key role in ensuring the highest standards of safety...