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Clinical Data Manager

For a client located in Brussels, a company active in clinical trials on an international scale, we are actively looking for a Clinical Data Manager.

Job description

As Clinical Data Manager, you work under the hierarchical supervision of the Clinical Data Expert. You report on his/her activities and status of the study to the study team. 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 our studies.Those tasks will be carried out by the Clinical Data Manager with the close coaching of a Clinical Data Expert.

Responsibilities

Clinical trial protocol

  • You develop the Data Management sections of the clinical trial protocol
  • You define the visit schedule
  • You assist in the 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

Requirements

  • You have a professional Bachelor’s or Master’s degree in a health-related or scientific discipline
  • You are 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
  • You have good organizational & administrative skills
  • You are rigorous, attached to details
  • You have excellent analytical skills
  • You are a team player
  • Your English is very good (written & spoken), French & Dutch are assets