For one of our client located in Brussels, we are looking for an enthusiastic Clinical Data Manager.
- Do you have a Professional Bachelor’s or a Master’s degree in a health-related or scientific discipline?
- Do you have programming skills as well as skills in the use and management of computer databases?
- Are you fluent in English (oral and written)?
Then you might be the candidate we are looking for. Don't hesitate and apply now!
As a Clinical Data Manager, you are responsible for the collection and processing of all the relevant information required for the set up of a clinical trial/cleaning of the data/reporting to the group.
You work under the hierarchal supervision of the Clinical Data Expert within the Data Management Department. You report on his/her activities and status of the study to the Clinical Research
Physician, Statistician & Project Manager.
- You are in charge of the Development of the Data Management sections of the clinical trial protocol
- You are responsible for assisting the final review of the clinical trial protocol for consistency
- You are responsible for the development of the Case Report Forms in accordance with the protocol and the database
- You set & create the Case Report Forms in the database
- You develop the guidelines for Case Report Forms completion
- You coordinate and control the data collection, data cleaning, and data reporting activities
- You are responsible for the application of QC to each stage in the data handling to ensure the data are reliable and processed in compliance with ICH-GCP requirements
- You communicate with the participating investigators in order to resolve queries and collect missing data
- You perform the reconciliation of SAEs with the Clinical Database
- You are responsible for the development and the maintenance of data validation plans for the studies
- You are responsible to edit checks and validation checks programs
- You prepare and attend the medical review meetings with the Clinical Research
- You prepare bi-annual EORTC Group Members newsletters on the studies under your responsibility
- You are responsible for the proper filling of all study related documents, in compliance with ICH-GCP requirements
- You have a Professional Bachelor’s or a Master’s degree in a health-related or scientific discipline
- You are computer literate
- You have programming skills as well as skills in the use and management of computer databases
- You have some Knowledge of CDISC standards, SDTM in particular
- A first experience in data monitoring and/or reviewing is an asset
- You have good organizational & administrative skills
- You are rigorous, attached to details and you have excellent analytical skills
- You are Team spirit oriented
- You are fluent in English (oral and written), French & Dutch are assets