• Clinical Trial Informatics SME

    Job Locations US-MD-Rockville
    # of Openings
    Information Technology
  • Overview


    Clinical Trial Informatics SME


    • Expertise in data and tools used for clinical trial planning, monitoring and organization, including Case Report Forms, Electronic Data Capture, and Clinical Trial Management Systems (such as Medidata Rave).
    • Experience with medical monitoring of trials and QC/curation of patient data prior to statistical analysis.
    • Knowledge of trial inclusion/exclusion criteria and enrollment metrics, and experience with commercial databases such as TrialTrove/SiteTrove.
    • Ability to work with clinical trial managers to elicit and document requirements for new software applications, and communicate those requirements to technical teams.
    • Ability to query clinical databases and generate data tables for analysis and QC.
    • Experience in operations of clinical trials in oncology and/or autoimmune diseases.
    • Effective written and oral communication skills.



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