p>Mylene Paumier at CK Clinical is recruiting for a Clinical Data Manager to join an international contract research organization at their site based in Belgium on a contract basis.
As Clinical Data Manager, you will have the following responsibilities:
- Content and structure analysis of the legacy data and the clinical trial protocol
- Annotation of Case Report Forms using CDISC Terminology
- Preparation of clinical data CDISC conversion definitions
- Development of project documentations (Data Reviewers Guide and Data Handling Report)
- Validation of the data and metadata according to the applicable CDISC standards and guidelines
- Quality Control of all project deliverables
- Responsibility for the timely delivery of a CDISC-compliant submission package
- Contribution to the definition of CDISC validation checks
As Clinical Data Manager, you will have the following qualifications, skills and experience:
- Master’s degree in scientific or healthcare discipline or equivalent through experience
- Experience in a clinical trial environment
- Strong understanding of data management and database administration: clinical protocol assessment, Case Report Form design, understanding of clinical data management systems, study start up (database administration, edit check creation/validation) and data base lock.
- CDISC knowledge is a plus
- Good knowledge of ICH/GCP
- Good English written and oral communication skills
- Quick learner
- Excellent team player
- Able to plan work in order to meet deadlines
How to apply
For more information or to apply for this Clinical Data Manager position, please contact Mylene Paumier on 0207 470 5672 or email: email@example.com. Alternatively, please click on the link below to apply online now. Please quote reference CL25844 in all correspondence.