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    Clinical Trial Lead - Boston, United States - System One Holdings, LLC

    System One Holdings, LLC
    System One Holdings, LLC Boston, United States

    1 week ago

    Default job background
    Description

    Title: Clinical Trial Lead


    Location: Boston, MA.


    Start Date:
    ASAP


    Duration: Contract-to-Hire


    Hours: Mon-Fri; 8:30am-5pm


    Overview

    Our client is a hospital which is internationally-known referral center for the most complex cases in nearly all areas of medicine.


    Some of their specialty areas include:
    Cancer, Heart, and Vascular.


    Requirements:


    • BS degree required
    • 23 yrs. of industry clinical trial experience from CRO, Pharma, Biotech or Healthcare setting is required.
    • Clinical trial database experience is required
    • Exp./Familiar with EDC, Medidata, RedCap or Inform is a plus but not required
    • Fully vaccinated with boosterREQUIRED

    Responsibilities:


    • Identify and initiate communications with sites to obtain all relevant documents for project/trial.
    • Collect and review essential regulatory documents for completeness prior to submitting to Regulatory for final review and/or approval
    • Advise research sites on protocol conduct, interpretation of protocol, and ensure resolution of issues.
    • Evaluate the quality and timeliness of data entry, issue, track and resolve queries, implement corrective action plans as needed.
    • Identify issues/trends that require escalation to management and provide input to resolution as appropriate
    #m3


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