Job content
The Clinical Data Standards Architect (CDSA)- Data Collection and Delivery implements and maintains efficient standard content in the data collection tools and delivery tools and defines and maintains the standard metadata supporting the data flow from data collection to data delivery.
The CDSA configures standards to the specific needs and requirements of a Therapeutic Area, compound our Disease Area, generating the expected efficiencies through optimal adoption and reuse of standards. The CDSA also supports the functions adopting the standards in the clinical trials, in close collaboration with the clinical data collection team.
Data collection focus only: The CDSA is responsible for implementing efficient standards in the Rave eDC system (Medidata Solutions).
The CDSA implements the standard content in the data collections and delivery tools with the goal of creating efficiencies within the trials, consistency across the trials and automating the CRF build and the data flow from collection to SDTM. Standard Case Report Form Mockups Standard Questionnaires, Rating Scales and Clinical Outcome Assessments
Standard Validation Rule Specifications Standard Integrations (e.g. with IWRS) Study Data Tabulation Model (SDTM) Annotated Case Report Forms (CRFs) Support the data transfer agreement (DTA) standards with SDTM Data Review Model (DRM: internal SDTM like model) Mapping metadata from data collection (CRF and DTA) to DRM Mapping metadata from DRM to SDTM
The CDSA implements standard content in the collection and delivery tools compliant to the industry standards and health authority regulations, meeting best computer system validation practices where applicable. The CDSA is responsible for the correct testing and QC of the collection tools and mapping metadata and therefore collaborates with the respective functions in Integrated Data Analysis and Reporting (IDAR). The CDSA defines and maintains the standard clinical data collection and the clinical data delivery standards for use in clinical trials.
The CDSA maintains the data collection and delivery and metadata standards at a master level to meet additional scientific or operational requirement supporting the RD portfolio. To that end the CDSA will guarantee formal change management control and versioning of the standards is applied and adhered to. The CDSA governs formally all the changes to standards and manages multiple versions in line with adoption needs of the clinical trials and drug development programs. The CDSA pre-configures the standards in line with the specifications of the data lifecycle plans, while maintaining the traceability and lineage of the data. The CDSA documents and manages correctly the lineage between master standards and the many pre-configured standards. The CDSA provides the necessary support to the clinical data standards team and the clinical analysis team who facilitate the consistent adoption of standards in the studies (internally or outsourced to a CRO). Data delivery focus only: T he CDSA annotates the CRF with SDTM metadata and collaborates with his/her team members on the correctness of the annotated case report form meeting submission, scientific and operational requirements and guidelines.
Primary interfaces: The global data collection lead in the standards team, the data collection experts in the standards, the data delivery leads in the standards team, the technical data architect and the data managers in the data management function Clinical Analysis Standards, the clinical team (statistician, physician, ), CDISC working groups.
Education and Experience Guidelines:
Data collection focus specific Deep expertise in Rave eDC (Medidata Solutions)
Experience with running SAS programs, coding experience preferred.
Data delivery focus specific:
Experience with coding and running SAS programs Knowledge of Rave eDC (Medidata Solutions) is a preferred Expertise with CDISC standards: SDTM, CDASH, Controlled terminology and define.xml.
Experience with SAS LSAF and Pinnacle 21 is a plus BS/BA degree in life sciences or computer science or equivalent by work experience 2 years of relevant operational experience in clinical data management or standards
Relevant operational experience in clinical data standards is preferred
Experience in prioritizing and managing multiple tasks simultaneously Outstanding written and verbal communication skills in English