Find a Meaningful Job at Eortc

il y a 2 semaines


Bruxelles, Région de Bruxelles, Belgique EORTC Temps plein
The Clinical Data Manager works under the hierarchal supervision of the Clinical Data Expert. The Clinical Data Manager reports on his/her activities and status of the study to the study team.

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 is to ensure adequacy, integrity and quality of the data that are used to answer the questions of our studies.


Clinical Trial Management:

The Clinical Data Manager will carry out those tasks 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 the final review of the clinical trial protocol for consistency and compliance with the EORTC Global Library for Case Report Forms
  • Case Report Forms
  • Development and definition of the studyspecific Case Report Forms in accordance with the protocol and the database
  • Development of the guidelines for Case Report Forms Completion
  • Database Design and Validation
  • Definition of the requirements for database design by the Study Designer
  • Development of the test plan and user tests for database validation
  • Execution of user tests regarding the database validation
  • 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 when applicable
  • Other
  • Development and maintenance of the data management plans for the studies
  • Preparation and attendance of the medical review meetings with the Clinical Research Physician

Other:

  • Preparation of biannual EORTC Group Members newsletters on the studies under her/his responsibility
  • Proper filing of all studyrelated documents, in compliance with ICH-GCP requirements

Profile:

  • Professional Bachelor's or Master's degree in a healthrelated 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 is very good (written & spoken), French and Dutch are assets

Benefits:

  • 30 days holidays Competitive Salary Package DKV Hospitalization insurance Free parking Hybrid working environment Full reimbursement public transport Meal vouchers Pension plan Permanent contract Homeworking allowance


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