Covance

  • Start-up Specialist II

    Job Location(s) UK-Leeds
    Job Number
    2018-21082
    Job Category
    Administration/Clerical
    Position Type
    Full-Time
  • Job Overview

    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 Study Start-up Specialist II to join the Clinical Operations in our internal Covance team Leeds, UK. We are looking for candidates experienced within: administration, clinical submissions, budget, contract negotiations.

     

    This is a full time permanent position, focused on operational and administrative tasks.

     

    About the Job:

     

    The Site Start-up Supervisor oversees tasks related to the conduct of clinical trials in the start-up phase and at times, maintenance phase. This may be inclusive of international clinical trials but focus will be primarily UK.Responsible for provision of client deliverables on-time, within budget and scope and with required quality for assigned projects or program.

     

    This role also drives documentation for the project, ensuring the accuracy and quality of regulatory data. They will surpervise and assess the performance of the core team members and motivate, train and develop the teams expertise to ensure efficient and effective day-to-day operations, while maintaining good relationships with sponsors.

     


    At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.

    Education / Qualifications

    Required:

      • University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.   In lieu of the above requirements, candidates with > six (6) years supervisory experience in a health care setting and four (4) years clinical research experience in the pharmaceutical or CRO industries will be considered
      • Working knowledge of time and cost estimate development.
      • Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
    • Broad knowledge of drug development process and client needs.

     

    Preferred:     

    • Masters or other advanced degree
    • Working knowledge of Covance and the overall structure of the organization.
    • Basic knowledge of Covance sales and business development strategies and procedures.
    • Working knowledge of Covance SOPs.

    Experience

    Required:

    • Minimum of five (5) years relevant clinical research experience including demonstrated skills and competency in clinical project management tasks, especially regarding study start-up.
    • In lieu of the above requirements, candidates with five (5) years supervisory experience in a heath care setting and five (5) years clinical research experience with at least one (1) year project management experience in the pharmaceutical or CRO industries will be considered.
    • Experience in managing projects in a virtual environment.
    • Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
    • Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
    • Demonstrated ability to lead by example and to encourage team members to seek solutions independently.
    • Excellent communication, planning and organizational skills.
    • Ability to review/analyze and report relevant data and interpret protocols and regulatory documents.
    • Ability to work independently.
    • Ability to negotiate and liaise with clients in a professional manner.
    • Ability to present to staff at all levels.
    • Strong computer skills with an ability to understand, access and leverage technology alternatives..
    • A working knowledge of ICH GCP, US FDA and MHRA regulations, regulations applicable to local office, guidelines, and practices regarding Good Clinical Practices.

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