Clinical Data Manager

Main responsibilities / Major Activities

The Clinical Data Manager is responsible for all the steps required for the setup of the Data Management tools of a clinical trial and for the collection, review and validation of the clinical data in a timely manner; this to ensure adequacy, integrity and quality of the data that are used to answer the questions of our studies.

  • Clinical Trial Management

Those tasks will be carried out by the Clinical Data Manager with the close coaching of a Clinical Data Expert:

  • Clinical trial protocol
    • Development of the Data Management sections of the clinical trial protocol
    • Defining the visit schedule
    • Assisting in final review of the clinical trial protocol for consistency
  • Case Report Forms
    • Development of the Case Report Forms in accordance with the protocol and the database
    • Definition of the Case Report Forms specifications
    • Development of the guidelines for Case Report Forms completion
  • Data handling
    • Coordination and control of data collection, data cleaning and data reporting activities
    • Application of QC to each stage in the data handling to ensure the data are reliable and processed in compliance with ICH-GCP requirements.
    • Communication with the participating investigators in order to resolve queries and collect missing data
    • Performing the reconciliation of SAEs with the clinical database
  • Other
    • Development and maintenance of the data management plans for the studies
    • Development of edit checks specifications
    • Preparation and attendance of the medical review meetings with the Clinical Research Physician

 

  • Other
    • Preparation of bi-annual EORTC Group Members newsletters on the studies under her/his responsibility
    • Proper filing of all study related documents, in compliance with ICH-GCP requirements

Profile

  • Professional Bachelor’s or Master’s degree in a health-related or scientific discipline
  • Computer literate; programming skills as well as skills in the use and management of computer databases are strong assets
  • Knowledge of CDISC standards preferred, SDTM in particular
  • Experience in data monitoring and/or reviewing is an asset
  • Good organizational & administrative skills
  • Rigorous, attached to details
  • Excellent analytical skills
  • Team spirit
  • English very good (written & spoken), French & Dutch are assets

Application form


*Compulsary fields
Application should be sent in English

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