Zuid-Holland , Netherlands
Clinical Data Standards Architect - Delivery Specialist
Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of monoclonal antibodies to protect people worldwide from immunological diseases.
As a Clinical Data Standards Architect you will implement and maintain standard content specifications for the data delivery tools?(SAS, LSAF Excel based libraries) across different therapeutic areas.
You will also define the?standard?delivery metadata supporting the data flow from data collection to data delivery (DRM and SDTM).
- Implement standard metadata in the data delivery tools to ensure consistency across trials.
- Automate the data flow from source data to DRM and to SDTM. Examples: Study Data Tabulation Model (SDTM), Annotated Case Report Forms (CRFs), Support the data transfer agreement (DTA) standards with SDTM, Data Review Model (DRM)
- Ensure data delivery tools comply with industry standards and?health authority regulations,?meeting?best practices in computer system validation.
- Testing and QC of the mapping metadata and therefore collaborate with the respective functions in Integrated Data Analysis and Reporting (IDAR).??
- Annotate the eCRF or eCOA with SDTM metadata.?
- Maintain the?clinical data delivery standards in line with the needs.
- Tailor the global data standards to the specific needs of Therapeutic Areas or Disease Ares,?while maintaining the traceability and lineage of the?metadata.????
- Provide support to the clinical programming teams to achieve consistent adoption of standards in the studies.
- University degree in Life Sciences or Computer Scienc.
- 3 years of experience in a similar role
- Experience with coding and running SAS programs
- Expertise with CDISC standards: SDTM, Controlled terminology and?define.xml
- Knowledge of Rave eDC (Medidata Solutions)?is preferred
- Experience with clinical data standards is preferred
- Experience with SAS LSAF and Pinnacle 21 is a plus
For more information please contact Carla Garcia at email@example.com or +31 (0) 20 658 98 01.