• Clinical Data Manager

    Posted Date 3 weeks ago(1/3/2019 1:19 PM)
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  • 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 Data Manager to support the National Institutes of Health (NIH).  It is a full-time position located on-site at NIH in Bethesda, MD.


    Data Manager will lead the end-to-end delivery of data management services, primarily focused on preclinical and clinical studies. Leads the delivery of data management products (clinical trial databases, data management documentation as well as data management study reports) per timelines and project specifications. Complies with Good Clinical Practices (GCPs), applicable regulatory guidelines, Standard Operating Procedures (SOPs), Clinical Trials Data Management best practice guidelines, as well as Good Clinical Data Management Practices documents.

    • Serve as the main contact on Data Management (DM) activities and provide strategic DM expertise to preclinical and clinical studies.
    • Preserve strong relationships with study sites and collaborators through open, efficient and timely communications.
    • Manage and resolve issues related to Data Management deliverables by developing solutions to complex problems to ensure consistency across study sites.
    • Participate in protocol development and design, develop, and review Case Report Forms (CRF). Ensure review and quality control against associated study protocol, NIAID laboratory requirements, CRF standards templates, Good Clinical Data Management Practices, and where applicable CDISC CDASH standards.
    • Plan and lead study database setup, ensuring appropriate database documenting.
    • Perform database validation as well as User Acceptance Testing (UAT), and document databases in accordance with programming standards and validation procedures.
    • Responsible to set up and review Data Management documentation, clearly outlining the project data management processes.
    • Responsible to monitor data management operational activities through quality control procedures, identifying individual and systemic data anomalies, as well as institution of corrective and preventative action plans (e.g. additional edit checks, data monitoring reports and/or listings, email alerting, etc.).
    • Understand and comply with GCP, SOPs, regulatory requirements, and Good Clinical Data Management Practices.
    • Work with and train local site data managers to understand and comply with GCP, SOPs, regulatory requirements, and Good Clinical Data Management Practices.
    • Meet objectives as assigned and interact with study teams to organize timelines, responsibilities and data management deliverables.
    • Build and maintain strong communication and working relationships with internal and external team members (timely email communication, telephone meeting as well as face to face meeting attendance).
    • Develop, implement, test, and monitor quality control of new technologies with guidance from Clinical Trials Data Management team as well as more experienced team members.
    • Develop data management training tools and train sites in data collection, data quality, and database use.
    • Review and develop Data Management SOPs and Clinical Trials Data Management best practice guidelines.
    • Extract and merge data sets from databases into the desired format for evaluation by other team members for QC or report purposes.
    • Other activities determined as important by management team.
    • International travel for 1-2 weeks at a time 2-4 times each year


    • Knowledge of data management processes and systems (specifically clinical data management systems)
    • Understanding of clinical trials and the drug development process
    • Proficient in SAS, R, or other programming languages. Knowledge of DataFax is desired but not required.
    • Good written and oral communication skills
    • Leadership and project management skills
    • Excellent organizational and analytical skills
    • Effective problem and conflict resolution skills
    • Ability to work independently and in a global team environment
    • High attention to detail and accuracy
    • Chinese (Mandarin) language skills are required
    • Previous experience in tuberculosis or infectious disease trials or trials with cure as an end point is desirable but not required.
    • Bachelor’s degree or educational equivalence in clinical, biological, mathematical or computer science with a minimum of 3 - 5 years relevant work experience in clinical research; OR equivalent combination of education, training and experience.

    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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