Clinical Data Manager
As Clinical Data Manager, 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.
As Clinical data manager, YOUR MAIN RESPONSIBILITIES are:
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
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 Group Members newsletters on the studies under her/his responsibility
- Proper filing of all study related documents, in compliance with ICH-GCP requirements
- A Professional Bachelor’s or Master’s degree in a health-related or scientific discipline
- Skills in the use and management of computer databases
- Good organizational & administrative skills
- Excellent analytical skills
- A good team spirit
- Experience in data monitoring and/or reviewing is an asset
- Knowledge of CDISC standards is a strong asset
- And an excellent command of English, written & spoken (French & Dutch are assets)
Rigorous, attentive to details and computer literate.
A highly stimulating, professional & friendly atmosphere in an international environment, and employees’ benefit.
You need more information? Call me at 02/801.16.65 !
Ready to apply? Please send me your CV and your cover letter for this position : email@example.com