• Start-up Specialist I

    Job Location(s) BR
    Job Number
    Job Category
    Clinical Operations
    Position Type
  • Job Overview

    Start-up Specialist I job. Office Based, Sao Paulo, Brazil




    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 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 our Specialist you will:
    • This is an office based job in Sao Paulo, Brazil
    • 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 2 years clinical research experience



    THE JOB 

    • Drive Feasibility, Site identification and Pre-qualification activities
    • Collect, review, approve, process and track regulatory & investigators documents required for study site activation in accordance with Covance and sponsor SOPs, GCP ICH
    • Prepare IRB/IEC submission packages, in accordance with relevant regulations, SOPs, and study specific procedures
    • Negotiate contracts and budgets with investigative sites within parameters provided by Sponsor
    • Essential Documents customization (Informed Consent, Advertisements, labels, protocols) WHAT WE´LL OFFER YOUJoin 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… we can offer you not only a job, but a stable, long-term international career.




    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) AND 2 years work experience in clinical research, 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; previous interaction with operational project teams and investigative sites
    • Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
    • Good organizational and time management skills
    • Excellent communication / writing skills
    • Strong computer skills with an ability to access and leverage technology alternatives
    • Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies
    • Self-motivation with the ability to work under pressure to meet deadlines
    • Works well independently as well as in a team environment
    • Detail and process oriented
    • Positive attitude and approach
    • Multi-tasking capability
    • Ability to work independently


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