Green Key Resources

Senior Clinical Data Manager

Green Key Resources United States
Green Key Resources

Senior Clinical Data Manager

Green Key Resources United States
3 weeks ago
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Duties

  • Leads all data management activities for one or more clinical trials.
  • Maintains and enforces Data Management timelines and metrics.
  • Manages Data Management vendor.
  • Ensures quality database design, coordinates User Acceptance Testing (UAT) and approves EDC databases.
  • Develops and oversees the Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
  • Oversees the development of Case Report Forms (electronic or paper) in collaboration with the clinical team and approves final versions.
  • Oversees the development of edit checks and approves final versions.
  • Creates and maintains data management plans (DMP).
  • Oversees and leads data cleaning and coding activities.
  • Participates in the review of clinical documents (e.g., protocols, case report forms, SAPs, TLFs.
  • Reconciles electronic data transfers (e.g., clinical laboratories, SAEs) from vendors.
  • Coordinates the archiving of study databases and related documents in Trial Master File (TMF).
  • Writes SOP’s and contributing to the improvement of Data Management processes.
  • Other duties as assigned

Skills

  • 5+ years of relevant data management experience in clinical trials.
  • CNS/Neuro experience
  • Working knowledge of database applications.
  • Proficient with EDC technology (e.g., RAVE, INFORM).
  • Familiarity with MedDRA/WHO-Drug.
  • Working knowledge of industry standards such as CDISC (SDTM and CDASH).
  • Experience in CNS is preferred.
  • Bachelor’s degree
  • Nursing/medical/biology/ background will be a plus.

  • Seniority level

    Mid-Senior level

  • Employment type

    Full-time

  • Job function

    Research, Analyst, and Information Technology

  • Industries

    Staffing and Recruiting

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