For one of our clients located in the east of Brussels, we are looking for an enthusiastic Clinical Data Manager (M/F).
- Do you have a University Degree in a health-related or scientific discipline ?
- Do you have computer databases management skills ?
- Are you fluent in English ?
Then, you might be the candidate that we are looking for !
As Clinical Data Manager, you work under the hierarchal supervision of the Clinical Data Expert. You report on your 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 the studies.
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 consistence
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
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
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 company’s Group Members newsletters on the studies under her/his responsibility
Proper filing of all study related documents, in compliance with ICH-GCP requirements
- You have a University Degree in a health-related or scientific discipline
- You are computer literate
- You have programming skills or experience in the use and management of computer databases (Master Thesis or Internship)
- You have good organizational & administrative skills
- You are rigorous & attached to details
- You have excellent analytical skills
- You have a strong team spirit
- You are fluent in English (written & spoken)
+32 10 68 53 30