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 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. 

The CDSA is responsible for implementing efficient standards in the Rave EDC system (Medidata Solutions). 

Responsibilities:

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.Examples of standard content for the data collection focusStandard Case Report Form Mockups Standard Questionnaires, Rating Scales and Clinical Outcome Assessments Standard Validation Rule Specifications Standard Integrations (e.g. with IWRS) Examples of standard content for the data delivery focusStudy Data Tabulation Model (SDTM)Annotated Case Report Forms (CRFs)Support the data transfer agreement (DTA) standards with SDTMData Review Model (DRM: internal SDTM like model)Mapping metadata from data collection (CRF and DTA) to DRMMapping metadata from DRM to SDTMImplements 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.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.  Defines and maintains the standard clinical data collection and the clinical data delivery standards for use in clinical trials. Maintains the data collection and delivery and metadata standards at a master level to meet additional scientific or operational requirement supporting the R&D portfolio. To that end the CDSA will guarantee formal change management control and versioning of the standards is applied and adhered to.Governs formally all the changes to standards and manages multiple versions in line with adoption needs of the clinical trials and drug development programs. Pre-configures the standards in line with the specifications of the data lifecycle plans, while maintaining the traceability and lineage of the data. Documents and manages correctly the lineage between master standards and the many pre-configured standards.   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: 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.

Education and Experience:

Deep expertise in Rave EDC (Medidata Solutions) Experience with running SAS programs, coding experience preferred.Experience with coding and running SAS programsKnowledge of Rave EDC (Medidata Solutions)Expertise with CDISC standards: SDTM, CDASH, Controlled terminology and define.xml. Experience with SAS LSAF and Pinnacle 21   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  

This role is not eligible for UK visa sponsorship

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com