Clinical Data Manager – Data Integration Specialist
at Business & Decision in Belgium
Business & Decision is a multi-national consulting company specializing in services and solutions for the Life Sciences Industry, most importantly in data management, SAS programming, biostatistics, medical writing and clinical trials expertise.
With more than 100 clients in Belgium and Europe, including most major players in the pharmaceutical/clinical sector, and a CDISC recognized partner, we are one of the best in our field.
The Clinical Data Manager – Data Integration Specialist is a key member of a multidisciplinary team involved in implementing CDISC data standards in clinical trials.
As such, you convert legacy (or on-ongoing) clinical study data and metadata into a CDISC format in order to comply with the Food and Drug administration (FDA) submission requirements, or prepare clinical data into a data warehouse ready format in order to maximize its usability.
In this process, your main responsibilities are as follows:
- 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
- Master’s degree in scientific or healthcare discipline or equivalent through experience
- A minimum of 1 to 3 year(s) 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
- Basic SAS knowledge
- Good English written and oral communication skills
- Quick learner
- Excellent team player
- Able to plan work in order to meet deadlines
We offer you the opportunity to be trained on the CDISC data standard with us as European leader in this domain.
At Business & Decision Life Sciences, you will be working in a pleasant environment 5 minutes away from the metro and the Ring, with flexible hours as well as an extensive package including company car and fuel card, net allowances, expenses, full group and hospitalization insurance coverage, etc.