Job Details

  • Title: Clinical Data Manager
  • Code: RCI-9901
  • Location: Osseo Minnesota (MN) 55311
  • Posted Date: 01/11/2021
  • Duration: 6 Months
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  Job Description

  • Participates in or leads the review of Clinical Research (CR) documents (e.g., protocols, reports and statistical analysis plans) by interacting with various CR groups including: Project Managers, Clinical Scientists and Statisticians.
  • Leads data management activities by working with Clinical Scientists, Clinical Research Associates, Clinical Safety Monitors, Systems Analysts, QC Analysts & Standards Librarian.
  • May s draft Data Management Plannd Data Review Plans as required.
  • Leads the development and defines standard and non-standard edit check specifications by utilizing clinical knowledge to create the parameters surrounding data items.
  • Provides significant input to CRF/eCRF design and address technical issues and edit check programming, as well as contributes to the development of data management reports of clinical data.
  • Leads Clinical Data Management activities by using Clinical knowledge, data listings and manual review of eCRFs to issue queries and clean data as required.
  • Contributes to the monitoring of data quality during study conduct
  • Provides information on issues along with proposed solutions
  • Ensures data snapshots are ready for analysis by following the guidelines established in the DMP and/or applicable SOPs.
  • Ensures database lock/unlock by following the guidelines established in the DMP and/or applicable SOPs.
  • Ensures archiving of the study databases and related documents by following the guidelines established in the DMP and/or applicable SOPs.
  • Leads the preparation and presentation of data management activities by evaluating and testing new systems and by participating in task force initiatives.

 

QUALIFICATION

 

  • Bachelor's degree plus 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.