Description
Clinical Data Standards Librarian - Antwerp Region
Profile
- Previous experience as a Data Standards Librarian with knowledge of library theory, build and maintenance and its application within the business. Implementation experience within an EDC environment.
- An advanced knowledge of CDASH and SDTM submission principles as well as hands on practical experience in applying these principles
- The drive to maintain knowledge in industry trends in standards.
- Understand the concepts and advantages of standardization.
- Experience with sound knowledge of the DM process and knowledge of the role of the other clinical research functions in the process. Multi-TA experience desirable to understand some of the differing requirements of TA standards
- Ability to quickly adapt into different corporate environments
The drive to maintain knowledge in industry trends in standards.
- Understand the concepts and advantages of standardization.
- Sound knowledge of the DM process and knowledge of the role of the other clinical research functions in the process. Multi-TA experience desirable to understand some of the differing requirements of TA standards
- Ability to quickly adapt into different corporate environments
Tasks
- Create and maintain Platform Independent (PI) CDASH compliant layouts from input provided by Global and Therapeutic area library teams according to industry standard and client specific business rules
- Create and maintain Platform Independent SDTM compliant annotations mapping the CDASH variables to SDTM variables according to industry standards and client specific business rules
- Create and maintain CDASH and SDTM compliant metadata using the Metadata Repository tool to complement the CDASH/SDTM layouts at all metadata layers
DCM Level (Data Collection module CDASH and SDTM)
Domain level
Variable level
Value Level Metadata
Controlled Terminology level
Computational Algorithms level
- Ensure consistency between Global and TA layouts and metadata
- Liaise with Standards Library eCRF developers to ensure that Platform Independent standards are suitable for development in a Front End environment
- Liaise with Data Collection Lead and Data Delivery lead to ensure CDASH/SDTM metadata structure is consistent with Industry Standard and client specific business rules particularly for Therapeutic Area standards that are required that have no current Industry standard available
- Work on several library development projects concurrently as well as performing maintenance on previously released libraries according to the client Data Standards Governance Process
- Maintain expert knowledge in current Industry Standards Development and initiatives
- Participate in standards related process improvement and other development workshops