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    Clinical Trials Manager - West Chester, United States - Pioneer Data Systems

    Pioneer Data Systems
    Pioneer Data Systems West Chester, United States

    1 week ago

    Pioneer Data Systems background
    Description

    Position Details:


    Our client, a world-leading Pharmaceutical Company in West Chester, PA is currently looking for a Clinical Trials Manager join their expanding team.


    Job Title:
    Clinical Trials Manager / Hybrid Work

    Duration: 12 months contract, extendable up to 24 months


    Location:
    West Chester, PA

    Hybrid. 3 days in office and 2 from home.


    Note:


    The client has the
    right-to-hire you as a permanent employee at any time during or after the end of the contract.

    You may participate in the company group
    medical insurance plan


    Job Description:

    Will Operational support for Global Medical Affairs, Governance, oversight and operational support

    Review milestones, review and support entry and information to track clinical studies

    Ensure inspection readiness of clinical studies

    Help local study team's start-up their studies

    Work with sites, get start up documents, set up monitoring plans

    Must have experience with Clinical Trials and studies around SOP development & review

    Regulatory and quality inspection readiness experience

    Medical affairs experience in the post marketing study phase experience Ideal

    Clinical Trial Manager / Clinical Project Manager/ Clinical Project Manager with regulatory experience will be an Ideal fit

    Study oversight, start-up and tracking


    Qualifications:
    3-5 years of experience

    BA/BS in life sciences will be ideal, Advanced degree a plus

    Daily engagement with local study leads, Sr. Global Managers tracking day to day clinical activities

    Must have experience in clinical study start-ups

    Veeva Experience a plus

    Experience in CTMS including Veeva Masterfile helpful

    Position will revolve around Post approval trials

    Candidates will early clinical trial experience without Medical affairs experience will also be considered


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