• Clinical Data Manager

    Posted Date 4 weeks ago(10/18/2018 12:30 PM)
    Job ID
    2018-3220
    # of Openings
    1
    Job Location(s)
    US-MD-Bethesda
    Category
    Research
  • Overview

    Medical Science & Computing (MSC) is an exciting growth oriented company, dedicated to providing mission critical scientific and technical services to the Federal Government. We have a distinguished history of supporting the National Institutes of Health (NIH) and other government agencies. MSC offers a dynamic and upbeat work environment, excellent benefits and career growth opportunities.

     

    We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, Pre-Tax Transit Assistance and tuition reimbursement. If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!

     

    Duties & Responsibilities

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

     

    The Clinical Data Manager provides subject matter expertise for clinical research oversight and mentors and trains junior data managers. The Clinical Data Manager oversees data management of multiple complex studies, reviews data at critical time points, assesses the quality of the statistical programming processes, and serves as an internal data management expert.

    Duties & Responsibilities

    • Manage Clinical Data Management project timelines on multiple complex studies or programs in accordance with protocol specific data management plans.
    • Provide technical oversight and complete CRF and 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.
    • Prepare clinical trial data for FDA regulatory audits.
    • Review the development of database specifications, validation plans, and data management plans; ensuring alignment with case report forms, protocol, and safety data standards.
    • Train junior data managers on clinical trial database and data management processes and procedures.
    • Provide input on the clinical data management system enhancements including performing UAT (User Acceptance Testing).
    • Participate in cross-functional process initiatives including standardizing clinical data management processes and procedures.

    Requirements

    Requirements

    • Bachelor’s degree in a scientific or allied health field (or equivalent degree), Master’s degree preferred.
    • Eight (8) 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.
    • Experience with personnel oversight and training.

     

    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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