• Clinical Data Analyst

    Posted Date 4 months ago(7/10/2018 2:13 PM)
    Job ID
    2018-3045
    # of Openings
    8
    Job Location(s)
    US-MD-Bethesda
    Category
    Science
  • Overview

    Medical Science & Computing is searching for a Clinical Data Analyst to support the National Institutes of Health (NIH). This opportunity is full-time, and it is on-site in Bethesda, MD.

    Duties & Responsibilities

    • Oversee sponsor Clinical Data Management project timelines on multiple complex studies or programs.
    • Provide technical oversight of service providers performing core data management functions including CRF/ edit check development, user acceptance testing, data cleaning, listings review, and database lock procedures.
    • Responsible for the oversight of clinical data management study deliverables, evaluates and mitigates risks across programs.
    • Assess the quality of the statistical programming processes through techniques including but not limited to good documentation code review, and testing.
    • Conducts data reviews.
    • Review the development of database specifications, validation plans, and data management plans; ensuring alignment with case report forms, protocol, and safety data standards.
    • Provide input on the clinical data management system enhancements including performing UAT (User Acceptance Testing)
    • Participate in cross-functional process initiatives.

    Requirements

    • Bachelor’s degree in health, IT or computer science. Four (4) years of specialized experience plus a high school diploma is equivalent to a Bachelor’s degree.
    • Four (4) years’ experience in data management.
    • Familiarity with computer platforms and statistical packages. 
    • Experience in creating data management tracking systems, error-checking procedures and back-up procedures to prevent loss of data. Knowledge of Federal information technology, the Biotech or Pharmaceutical Industry, or equivalent comparable background.
    • Experience with clinical trial databases, multiple clinical trial data management systems, and electronic data capture (EDC)
    • Working knowledge of GCP and Human Research Subjects Protection guidelines, as well as regulatory requirements relating to clinical development and compliance with safety, ethical, legal and regulatory standards preferred
    • Demonstrated current understanding of the regulations as they relate to clinical trial data management systems and activities; demonstrated current understanding of Good Clinical Data Management Practices (GCDMP)
    • Project management experience is required. Must have experience managing timelines.

    Medical Science & Computing is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

     

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