About the Role:
Laura Christie is currently recruiting for an experienced Clinical Data Standards Specialist to join an international company on a permanent basis in Belgium. The position is office based and includes an excellent salary plus benefits and assistance with relocating.
Main duties and responsibilities:
· 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
· Create and maintain CDASH and SDTM compliant metadata using the Metadata Repository tool to complement the CDASH/SDTM layouts at all metadata layers
a. DCM Level (Data Collection module CDASH and SDTM)
b. Domain level
c. Variable level
d. Value Level Metadata
e. Controlled Terminology level
f. Computational Algorithms level
· Create and maintain Platform Independent front edit checks from input provided by the Global and Therapeutic area library teams
· Create and maintain Platform Independent completion guidelines from input provided by the Global and Therapeutic area library teams
· 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 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 Data Standards Governance Process
· MSc or PhD in medical statistics mathematics, statistics or life sciences
· 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.
· Five plus years experience within Pharmaceutical/CRO industry 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
#A full job spec is available upon request#
If you have the skills and experience for this role, please contact Laura Christie with your updated CV on [... Click Apply...]928 or email [... Click Apply...] to learn more. Alternatively, please click on the link below to apply online.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL38477 in all correspondence.