Clinical Data Manager

Scope of the Job

The Clinical Data Manager is responsible for the collection and processing of all the relevant information
required for the set up of a clinical trial / cleaning of the data / reporting to the group.

The Clinical Data Manager works under the hierarchal supervision of the Clinical Data Expert within the Data
Management Department.

The Clinical Data Manager reports on his/her activities and status of the study to the Clinical Research
Physician, Statistician & Project Manager.

Main responsibilities / Major Activities

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
  • 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 & creation of the Case Report Forms in the database
  • 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 data validation plans for the studies.
  •  Development of edit checks and validation checks programs.
  •  Preparation of and attendance to the medical review meetings with the Clinical Research Physician

Other activites

  • 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

The EORTC offers a highly stimulating, professional & friendly atmosphere in an international environment, and an attractive employee benefit package

Please send curriculum vitae and cover letter in English to:
Recruitment – EORTC Headquarters – Avenue E. Mounier 83, bte 11, 1200 Brussels, Belgium
Confidential fax: +32 2 770 78 11 – Email: recruitment@eortc.be

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