Covance

  • Start-up Specialist I

    Job Location(s) BE-Brussels
    Job Number
    2018-24056
    Job Category
    Study Start Up
    Position Type
    Full-Time
  • Job Overview

    Site Start-up Specialist job. Brussels. Permanent.

      

    COVANCE

     

    If you want to accelerate your Start-up Specialist career think long-term and the possibilities we can offer you:

     

    • We have helped the pharmaceutical industry develop more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today and
    • 100 % of all Oncology drugs approved in 2016.

     

    Explore this job as Start-up Specialist 1 with us and see why Covance has been named among the World´s Most Innovative Companies in Forbes´ 2017 Ranking, and more than 90% of the top 20 global pharmaceutical companies are repeat customers.

     

    As Covance is placing a big bet on creating a very strong and specialized Start-up Operations team in Belgium, with us you will have realistic International Start-up Leadership career progression opportunities.

     

     

    THE JOB

     

    This is an office based job in Brussels.

     

    You will have full accountability in facilitating the delivery of site start-up activities of your assigned trials. Among your main responsibilities you will:

     

    • Negotiate contracts and budgets with investigative sites within parameters provided by Sponsor,
    • Oversee timely collection of investigator and regulatory documents,
    • Prepare IRB/IEC submission packages, in accordance with relevant regulations, SOPs, and study specific procedures
    • Ensure ongoing accuracy and quality of site/study documents, (e)TMF filing and that systems are updated on an ongoing basis,
    • Country and Site Documents customization

     

     

    WHAT WE´LL OFFER YOU

     

    As a core member of our team, you will be expected to work autonomously and deliver on project phases on time and on budget. We will help you achieve your goals by continuous professional development, and regular career progression sessions.

     

    This is an exciting position within the Start-Up part of clinical trial where work-life balance is considered: flexi time and regular home based work after an initial trial period.

     

    But also importantly:

     

    • Forget the machine-like environment: we are a supportive community where everyone helps each other to succeed, and you will receive direct coaching from our expert managers.
    •  Your studies will be “yours” from the beginning until the Amendments stage: you will not jump from study to study without previous notice.

    Education / Qualifications

    You are educated to University/College degree (i.e. law, life sciences), or certification in a related allied health profession (e.g., nursing, medical or laboratory technology).

     

    Experience

    REQUIREMENTS

     

    This job will make a difference in our team, improving our way of working and actively seeking local efficiencies within global processes. This is why we need you to bring a minimum of two (2) years working experience being the primary contact person with investigative sites during start-up activities at either a CRO and/or a Pharmaceutical company. You may also be a CRA with some Start-up experience who wants to consolidate your career in this field.

     

    We need you to be fluent (both speaking & writing) in English, French and Dutch.

     

    • Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines;
    • Familiarity with investigator start-up documents and contract/budgets negotiation process;
    • Previous interaction with operational project teams and investigative sites;
    • Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them

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