Covance

  • Assoc Project Coordinator CPS

    Job Location(s) UK-Leeds
    Job Number
    2018-25635
    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 are recruiting for a Associate Project Coordinator for our Clinical Pharmacology Project Management team in Leeds. As an Associate Project Coordinator, you will support the team in meeting and exceeding client requirements through the creation, review, distribution and filing of study specific documents/tracking tools and by assisting with client and interdepartmental liaison activities. This is a full time, permanent position based in our Leeds Clinic.

     

    About the job

     

    • Assists the Project Manager in developing study specific documents (e.g. Project Management Plan, Communication Plan, Risk Mitigation Plan), including compliance with client-specific requirements, and routes final documents.
    • Assists the PM in the use of trial management tools, including project setup activities (e.g. study ID request, SAS Environment Setup request, Study-specific Distribution Lists, etc.); formats, posts, and compiles study timelines as required.
    • Attends study-related meetings; distributes meeting agendas; maintains and distributes meeting minutes, ADI and Risk Log, and study team contact lists.
    • Reviews presentations and correspondence upon PM request.
    • Maintains an internal standardized filing structure for study-related documents.
    • Upon request, posts documents such as CRA reports, project deliverables, trackers, regulatory documents, metrics, agendas, and minutes to client websites after completing administrator and program training on the client system.
    • Under the guidance of and with review by the PM, gathers appropriate regulatory documents and forwards them to the client to ensure on-time drug shipment.
    • Enters budgeted hours into the project timeline.
    • Assists the PM with document transfer to the Trial Master File (TMF) in accordance with applicable SOPs, policies, system, and client requirements.
    • As directed and with oversight, assists with business improvements initiatives to drive quality, productivity, and continuous improvements across different business units.
    • Upon PM request and with Associate Project Coordinator (PC) acceptance, may serve as a sponsor and site contact in the absence of the PM, especially during maintenance phases of routine trials.
    • Generates and delivers requested CD copies for clients and archive projects with oversight from a senior PC or PM.

     

    We Offer

     

    COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.

    Covance’s ongoing success offers team members unsurpassed growth and career development opportunities.

    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.

     

    There is no better time to join us!

    Education / Qualifications

    Recommended:

     

    • University/college degree, preferably in a healthcare/scientific field.
    • Specific clinical research experience may be substituted for education.

    Experience

    Minimum Required:

     

    • Knowledge of the clinical trial process with early clinical pharmacology experience preferred
    • Minimum 1-2 years of experience in a research environment
    • Knowledge of protocol designs, study objectives, study procedures, and project-related timelines
    • Knowledge of GCP/ICH Guidelines and applicable Regulatory Authority Guidelines

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