Clinical Data Manager

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Clinical Data Manager


Functieomschrijving

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 Head of 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.

Clinical Trial Management

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

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
  • Definition & creation of the study protocol in the database

Case Report Forms

  • Development of the Case Report Forms in accordance with the protocol and 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
  • Conduct of the reconciliation of SAEs

Other

  • Development and maintenance of data validation plans for the studies
  • Development of crosschecks and validation checks programs
  • Preparation of and attendance to the medical review meetings with the Clinical Research Physician
  • Preparation of bi-annual Group Members reports on the studies under her/his responsibility
  • Proper filing of all study related documents, in compliance with ICH-GCP requirements

Profiel

  • University Degree in life sciences (Biomedical, pharmacy, veterinarian…) 
  • Computer literate
  • Skills in the use and management of computer databases
  • Good organizational & administrative skills
  • Rigorous, attached to details
  • Experience in data monitoring and/or reviewing is an asset
  • Excellent analytical skills
  • Team spirit
  • English very good (written & spoken), French & Dutch are assets

Aanbod

Sollicitatieprocedure

Aline Vandermeeren: aline@arcq.be