• Clinical Data Manager Lead

    Job Location(s) US-NJ-Princeton | US-NC-Raleigh-Durham | US-TX-Dallas
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  • Job Overview

    Data management leadership on a large I global project, or multiple projects with responsibility for the development of the project Data Management Plan; data management systems set-up; and data accession, data entry and data review specifications and processes; and oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, and project timelines and budgets.

    + Develop and maintain a close liaison with project client contacts, core team members, and Project Managers to drive the data management aspects of project delivery.


      • University/col lege degree (l ife science, pharmacy or related subject preferred), or certification
      • in a related al lied health profession from an appropriately accredited institution (e.g., nursing ce11ification, medical or laboratory technology).
      • Additional relevant work experience will be considered in lieu of formal qualifications.
      • Broad knowledge of drug development processes.
      • Understanding of global clinical development budgets and relationship to productivity targets.
      • Knowledge of effective clinical data management practices.
      • Knowledge oftime and cost estimate development and pricing strategies.
      • Thorough knowledge of TCH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.


    Minimum five (5) years relevant work experience in data management with approximately one (1) year technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.

    • Demonstrated skill for technical management of staff exceeding 5 employees.
    • Financial management of gross revenues in excess of $250K per
    • Excellent oral and written communication and presentation skills.
      • In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operation
      • Working knowledge of the relationshi p and regulatory obligation of the CRO industry with pharmaceutical I biotechnological
      • Ability to lead by example teams on project strategies and achievement of depa11ment goals, objectives, and initiatives and to encourage team members to seek solutions.

      • Demonstrated managerial and interpersonal skills


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