Ga naar hoofdinhoud

Clinical Data Manager

Postulez ici

Aline Vandermeeren
Business Unit Manager


Postulez ici

Aline Vandermeeren
Business Unit Manager



Aline Vandermeeren
Business Unit Manager
+32 497 71 58 10


Description de l'emploi

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

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

Defining the visit schedule

Assisting in final review of the clinical trial protocol for consistency and compliance with the company's Global Library for Case Report Forms

Case Report Forms

Development and definition of the study specific 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

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

Profil

  • 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

Postes vacants connexes

Site Manager


Postulez maintenant pour Clinical Data Manager

Veuillez inclure vos coordonnées, votre formation et votre expérience afin que nous puissions voir rapidement si vous êtes le bon candidat pour le poste.

Coordonnées de contact

Formation et expérience

Nombre d'années d'expérience*

Postes vacants connexes

Site Manager


+32 497 71 58 10