Covance

  • Start-up Specialist II

    Job Location(s) DE-Munich
    Job Number
    2018-24144
    Job Category
    Study Start Up
    Position Type
    Full-Time
  • Job Overview

    Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning. 

    Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.

     

    COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. We have an exciting opportunity available to join our team.


    We are currently recruiting Start-Up Specialist II to join our Sponsor’s team
    in Munich, Germany. This is a regular full-time position.

     

    Duties and Responsibilities:

     

    • Primary contact with more challenging sites or those hosting complex studies.
    • The jobholder, working in a cross functional team, facilitates delivery of the site start-up (SSU) component of assigned studies within a country, including full accountability for delivery to time, cost and quality for assigned activities with minimal supervision.
    • The jobholder operates within the boundaries of assigned budget, provides guidance to internal and site staff around process and other operational issues.
    • Submits regular reports to Start-up Country Manager (SUCM) and project team regarding progress and challenges.
    • Develops and implements strategies for the earliest possible approval of regulatory submission by reducing the hours allocated to activate sites, maximizing the time for patient enrolment and actively seeking local efficiencies within global processes.

    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).

     

    Mandatory:

    • High proficiency with German language and English. Any other language is a plus.

    Experience

    • Minimum of 4 years of experience in clinical development or regulatory process.
    • Significant experience of applying strong 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.
    • Significant experience of issue escalation and resolution.
    • Proven track record of effective communication and problem solving.
    • Experienced in creating and maintaining good business relationships.
    • Proven ability to work under pressure with multiple internal clients with competing goals.

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