Ref #: 28555

Employment type: Permanent - Full-Time

Location: Europe

Posted: 21-Apr-2021


Title: Clinical Data Standards Architect (CDISC-SDTM).
Duration: Full Time Permanent Employment
Location: Multiple EU countries; UK, Ireland, Belgium, Netherlands, France & Germany or South Africa.

• Develop and maintain SDTM library standards used across all therapeutic areas.
• Delivering data standards such as SDTM, Controlled terminology and mapping metadata
• Configures standards to specific needs and requirements of Therapeutic area, Compound or Disease area generating the expected efficiencies through optimal adoption and reuse of standards.

- Implement the standard content in the data delivery tools, creating efficiencies within the trials, consistency across the trials and automating the CRF build and the data flow from collection to SDTM
- Support activities in : SDTM (Study Data Tabulation Model), aCRFs (Annotated Case Report Forms), DTA (Data Transfer Agreements), Data Review Model (DRM), mapping metadata from data collection to DRM and DRM to SDTM.
- Implements standard content in the delivery tools compliant to the industry standards and health authority regulations, meeting best computer system validation practices where applicable.
- Annotates the CRF with SDTM metadata and collaborates with team members on the correctness of the annotated case report form meeting submission, scientific and operational requirements and guidelines. 

Experience Requirements:
- At least 5 years of relevant experience in pharmaceutical industry within clinical trials in Clinical Programming / Clinical Data Management areas.
- University or college degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree
- Expertise with SDTM standards; experience with CDASH, Controlled terminology and define.xml would be highly beneficial.
- Experience with SAS, RAVE EDC, Pinnacle 21 would also be high beneficial.
- Prior experience in Clinical Data Standards