Description
Your role
Our client is a multi-national consulting and systems integration company specializing in services and solutions for the life science industry.
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 t o comply with the Food and Drug administration (FDA) submission requirements, or prepare clinical data into a Datawarehouse 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
Your profile
- 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
- Fluent English
- Quick learner
- Excellent team player
- Able to plan work in order to meet deadlines