• Start up and Contract Specialist - office based Lisbon

    Job Locations - | Portugal
    Posted Date 2 weeks ago(6/4/2018 10:17 AM)
  • Overview

    Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop lifesaving and life-improving drugs. We help change people’s lives for the better every single day. It’s who we are. And it’s who you could be too. Working fully embedded within one of our pharmaceutical clients, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation.


    We are looking for a Start up and Contracts Specialist office based in Lisbon.


    As a Start-up and Contracts Specialist, you will be dedicated to one of our global pharmaceutical clients; a company that is advancing the development of new medicines with a strong focus on oncology, among other therapeutic areas. Working in this model, you will be part of the most exciting projects together with an essential pharma company and a top 5 CRO across the globe.





    Typical responsibilities:



    • Coordinates, guides and assists with all start-up activities prior to site activation
    • Prepares country-specific informed consent form in line with regulatory/health authority requirements.
    • Manages Ethics committee and health authority submissions, amendments and communication.
    • Maintains up to date knowledge and compliance adherence with local regulatory requirements and associated documentation.
    • Ensures all start up information and requirements are kept up to date
    • Manages end-to-end contract work flow within the clinical operations department
    • Negotiate contracts and study budgets with sites during the study start-up phase to ensure finalization.
    • Ensures execution of approved and finalized contracts
    • Has oversight of contract negotiation/approval timelines/metrics and provides performance metrics to the clinical operations leadership group.
    • Assist with identification and tracking of new sites in collaboration with Clinical Study Managers.

    As a Start – up and Contracts Specialist , you will have the opportunity to experience the full lifecycle of a project and genuinely contribute to drug development and improving patients’ lives.



    You are:


    Passionate and responsible.


    Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:



    • University degree or equivalent preferably in a medical/science-related field.
    • Demonstrated knowledge and understanding of ICH-GCP/GPP, the regulatory, ethics and contractual requirements for starting clinical trials in the country.
    • Previous experience in a similar role
    • Demonstrated competence in analysis, planning and problem solving.
    • Excellent communications skills both in English and Portuguese
    • Able to make effective decisions, self-motivated, assertive, and displays initiative.
    • Demonstrated computer literacy, usage of MS Office software, web-based systems and databases


    PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.


    For more information please visit our website:


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