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Clinical Data Manager

Introduction


As Clinical Data Manager, you are 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 the studies.


Description d'emploi


As Clinical data manager, YOUR MAIN RESPONSIBILITIES are:

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

Besoins


You have:

  • A Professional Bachelor’s or Master’s degree in a health-related or scientific discipline
  • Skills in the use and management of computer databases
  • Good organizational & administrative skills
  • Excellent analytical skills
  • A good team spirit
  • Experience in data monitoring and/or reviewing is an asset
  • Knowledge of CDISC standards is a strong asset
  • And an excellent command of English, written & spoken (French & Dutch are assets)

You are:

Rigorous, attentive to details and computer literate.


Offre


A highly stimulating, professional & friendly atmosphere in an international environment, and employees’ benefit.


Information


You need more information? Call me at 02/801.16.65

Ready to apply? Please send me your CV and your cover letter for this position : sybille.ponet@xpepharmascience.com


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