Covance

  • START-UP SPECIALIST I, MADRID

    Job Location(s) ES-Madrid
    Job Number
    2018-25819
    Job Category
    Hidden (54293)
    Position Type
    Full-Time
  • Job Overview

     

    Start-up Specialist I job. Office Based, Madrid.

     

     

    COVANCE

     

    If you want to accelerate your Clinical 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 I with us and check for yourself why Covance is known to promote 2.5x more employees annually than the average company in the sector.

     

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

     

    THE JOB

     

    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 minimum 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations during start-up activities at either a CRO and/or a Pharmaceutical company.

     

    This is an office based job in Madrid.  

     

    As our Specialist you will:

     

    • Be the primary contact with assigned investigative site(s) during site start-up (SSU) activities with responsibility for collection of the required investigator and regulatory documents for a study, to ensure EC applications are made within the timelines agreed with project management and SU team and that documentation meets the specifications required by applicable regulations and sponsor.

     

    • Ensure Covance systems accuracy, reflecting site readiness to enroll.

     

    • Ensure clinical sites are ready for the first day that the drug trial begins.

     

    • Maintain allocated site’s information and associated regulatory documents throughout the duration of the clinical trial.

    Education / Qualifications

    University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)

     

     

    Experience

    Minimum of 2 years of experience in clinical development or regulatory process, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.

     

    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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