The Clinical Data Standards Architect (CDSA)- Data Collection and Delivery implements and maintainsu202fefficient standard contentu202finu202ftheu202fdata collection tools and delivery toolsu202fandu202fdefines and maintains theu202fstandardu202fmetadata supporting the data flow from data collection to data delivery. The CDSAu202fconfiguresu202fstandards to the specific needs and requirements of a Therapeutic Area, compound Disease Area, generating theu202fexpectedu202fefficiencies 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.u202f The CDSA is responsible for implementing efficient standards in the Rave EDC system (Medidata Solutions).u202f Responsibilities: Implements theu202fstandard 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 focus_ Standard Case Report Form Mockupsu202f Standard Questionnaires, Rating Scales and Clinical Outcome Assessmentsu202f Standardu202fValidation Ruleu202fSpecificationsu202f Standard Integrations (e.g. with IWRS)u202f Examples of standard content for the _data delivery focus_ 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 Implementsu202fstandard content in the collectionu202fand deliveryu202ftoolsu202fcompliant to the industry standards andu202fhealth authority regulations,u202fmeetingu202fbest computer system validation practices where applicable. Responsibleu202fforu202ftheu202fcorrectu202ftesting and QC of the collection tools and mapping metadata and therefore collaborates with the respective functions in Integrated Data Analysis and Reporting.u202fu202f Defines and maintainsu202ftheu202fstandardu202fclinical data collection andu202ftheu202fclinical data delivery standards for use in clinical trials.u202f Maintainsu202ftheu202fdata collection and delivery and metadatau202fstandardsu202fat a master level to meet additional scientific or operational requirement supporting the R&D portfolio. To that end the CDSAu202fwillu202fguarantee formalu202fchange management control and versioning of the standardsu202fis applied and adhered to. Governs formally all the changes tou202fstandardsu202fand manages multiple versions in line with adoption needs of the clinical trialsu202fand drug development programs.u202f Pre-configuresu202fthe standards inu202fline with the specifications of the data lifecycle plans,u202fwhile maintaining the traceability and lineage of theu202fdata. Documentsu202fand managesu202fcorrectly the lineage between master standardsu202fandu202ftheu202fmany pre-configured standards.u202fu202fu202f 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).u202fu202f _Data delivery focus only:_ Annotates the CRF with SDTM metadata and collaborates with his/her team members on theu202fcorrectness of theu202fannotatedu202fcase report form meeting submission, scientific and operational requirements and guidelines. Education and Experience: Deep expertise in Rave EDC (Medidata Solutions)u202f Experience with running SAS programs, coding experience preferred. Experience with coding and running SAS programs Knowledge of Rave EDC (Medidata Solutions) Expertise with CDISC standards: SDTM, CDASH, Controlled terminology andu202fdefine.xml.u202f Experience with SAS LSAF and Pinnacle 21 BS/BA degree in life sciences or computer science oru202fequivalent by work experienceu202f 2u202fyears ofu202frelevantu202foperational experience in clinical data managementu202for standards Relevant operational experience in clinical data standardsu202fis preferredu202f Experience in prioritizing and managing multiple tasks simultaneouslyu202f Outstanding written and verbalu202fcommunication skills in Englishu202f 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 IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled