ERT

  • Data Manager

    Job Location US-OH-Cleveland
    Shift
    40
    Type
    Regular Full-Time
  • Overview

    The Clinical Data Manager is responsible for managing timelines and targets for Sponsor data delivery. The Clinical Data Manager is the primary contact for all data management issues for both internal and external teams.

    Responsibilities

    ESSENTIAL DUTIES AND RESPONSIBILITIES:

     

    1. Serve as the primary internal and Sponsor contact for Data Management questions, issues or concerns including, but not limited to:
      1. Data delivery
      2. Data reconciliation
      3. Data Management activity timelines
    2. Define the Data Management Plan (DMP)
      1. Collaborate with Sponsors to define study requirements
      2. Determine standard edit checks necessary to ensure clean data and define new edit checks when standard checks are insufficient
      3. Collaborate with internal teams on study setup requirements such as demographic collection and visit schedule requirements
      4. Communicate contents and commitments in the DMP to the internal CDM teams
      5. Complete data management related pages in EXPERT (Cardiac or Pulmonary only.)

    3. Lead the development, review, and finalization of Data Transfer Specification (DTS) or Load Specifications (LS) and/or Edit Check Configuration documents (EC).Provide or customize ERT standard file specifications, review and/or consult with Sponsor on Sponsor-defined specifications and coordinate finalization and approval of file specifications between Sponsors and System Analysts.

      1. Maintain approved file specifications (DTS or LS).
      2. Perform any required validation of file formats or data content.
      3. Submit programming requests for data file creation or edit check creation.
      1. Ensure updates needed to the Tasklist or DMActiveWorklist for any Programming Work Requests (eWorkRequest or PRF) are entered and work is completed.
      2. Ensure high customer satisfaction by delivering on promises, meeting timelines and providing excellent customer service at all times.
      3. Identify out of scope requests and elevate these requests to the Project Manager so that they can be properly billed through the Change Order process.
      4. Ensure Data Management files are up-to-date and comprehensive including, but not limited to, Data management Plans, Data Transfer Agreements, Load Specifications
      5. Conduct routine status meetings with Sponsor/CRO and internal teams. Provide agenda and meeting minutes to all attendees.

       

      OTHER DUTIES AND RESPONSIBILITIES:

       

      1. Assist in the preparation of monthly reporting by providing metrics as required.
      2. Communicate project status clearly with Sponsors and Project Management.
      3. Contribute to continuous process improvement including workflow efficiencies and associated workflow documentation.
      4. Lead in CAPA issues related to study-specific data management activities.
      5. Assist with query escalation/data cleaning.
      6. Assist System Analyst with performing a transfer of study data if required.

     

    Qualifications

    QUALIFICATIONS AND SKILLS NEEDED: 

    1. BS/BA Degree in Life Sciences or related field preferred
    2. Minimum of 2 years Data Management or related experience preferably in a clinical research position
    3. Strong organizational, interpersonal, analytical and communication skills
    4. Detail-oriented.
    5. Knowledge or understanding of CDISC and SDTM
    6. Experience with Windows and Microsoft Office products preferred
    7. SAS and/or SQL exposure or experience is a plus
    8. Ability to communicate effectively in English

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