Clinical Data Manager

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!

Job Description 

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.

Responsibilities 
Clinical trial protocol
  • 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
Case Report Forms
  • 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
Data handling
  • 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
Other
 
  • 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
Profile 
  • 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
Contact Information 

Amandine Planche
010/68.53.30
amandine.planche@valesta.com

Application form : Clinical Data Manager

Files must be less than 3 MB.
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Files must be less than 3 MB.
Allowed file types: txt rtf html pdf doc docx odt.
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