4 days old
2018-06-202018-07-20

Manager, Clinical Data Management

Terumo
  • Job Code
    388176
JobId: 388176
JobTitle: Manager, Clinical Data Management
Department:
Location: Somerset Davidson
Description: Job Summary:
 
The Data Manager will work closely with the Clinical Project Managers to oversee data management activities performed by the designated EDC vendor and core lab(s) with the purpose to deliver a clean and complete database for statistical analysis.
 
 
Job Details:
  1. Develops Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to IDE study design and methodologies
  2. Reviews and provides input to IDE study protocol, Statistical Analysis Plan (SAP), and other documents collaborating with statistician
  3. Develops Case Report Form (CRF), electronic and\/or paper and its implementation with study teams and eDC vendor(s)
  4. Collaborates with external CRO for database programming to establish timely delivery of the clinical database setup, including creation and testing of edit checks; trouble-shoots to identify issues
  5. Develops database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules\/checks, query logic and data validations
  6. Leads EDC database (DB) specification process
  7. Develops Data Transfer Agreement(s) (DTAs) between external data vendors and\/or core labs
  8. Advises Study Team on Data Management related aspects, seeks clarification on specific study needs, provides status\/progress updates and highlights issues found during CRF review
  9. Participates in data review meetings and Clinical Event Adjudication meetings to discuss specific data values relevant for the analysis\/determining subject populations
  10. Maintains Data Validation Specifications (for computerized and manual checks), including testing computerized edit checks and ensures they are reviewed by the relevant stakeholders
  11. Acts as liaison for internal colleagues, as well as involved CRO and other vendors to agree upon data management related timelines
  12. Ensures specifications for the electronic data (i.e., angiography, ultrasounds, etc.) are created and provided to external vendor; in case of local hospital labs, ensures laboratory ranges and units are collected
  13. Performs, oversees, completes and provides accurate review and processing of clinical trial data, including identification, resolution and clarification of any missing, inconsistent or clinically questionable data by the study team and\/or sites
  14. Participates in reconciliation of Serious Adverse Events between Clinical and Clinical Event adjudication databases
  15. Generates data management study status\/progress overviews or ensures these overviews are created
  16. Reviews data management study status\/progress overviews and takes appropriate action
  17. Participates in CRO evaluation to ensure organization is in alignment across all Clinical Programs
  18. Performs other duties and responsibilities as assigned

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Manager, Clinical Data Management

Terumo

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Terumo

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