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CDS Architect Data Delivery

PE Global
Job LocationLondon
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

Services Overview:The Clinical Data Standards Architect (CDSA)- Data Delivery implements and maintainsefficient standard contentinthedata delivery tools(SAS, LSAF Excel based libraries) that can be applied across all the diseases areas and therapeutic areas or that are specific to a specific therapeutic are or disease area.The CDSA defines and maintains thestandarddelivery metadata supporting the data flow from data collection to data delivery (DRM[1] and SDTM). To that end, the CDSA is responsible for defining and maintaining the metadata supporting the Data transfer Agreements (DTA) with third parties, DRM and SDTM model and the data mapping of source data, eCRF data and third-party transfer data (eDT) to DRM and SDTMThe CDSAconfiguresstandards to the specific needs and requirements of a Therapeutic Area, compound, or Disease Area, generating theexpectedefficiencies 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 CDSA responsible for the data collection standards.Deliverables:

  • The CDSAimplements thestandard metadata in the data delivery tools with the goal of creating efficiencies within the trials, consistency across the trials and automating 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)
  • Mapping metadata from data collection (CRF and DTA) to DRM
  • Mapping metadata from DRM to SDTM
  • TheCDSA implementsstandard content in the deliverytoolscompliant to the industry standards andhealth authority regulations,meetingbest practices in computer system validation, where applicable.
  • TheCDSAisresponsibleforthecorrecttesting and QC of the mapping metadata and therefore collaborates with the respective functions in Integrated Data Analysis and Reporting (IDAR).
  • The CDSA annotates the eCRF or eCOA with SDTM metadata and collaborates with his/her team members on thecorrectness of theannotatedcase report form meeting submission, scientific and operational requirements, and guidelines.
  • TheCDSA defines and maintainstheclinical data delivery standards in line with the needs in clinical trials to meet additional scientific or operational requirements. To that end the CDSAwillguarantee that formalchange management control and versioning of the standardsis applied and adhered to.
  • TheCDSAgoverns formally all the changes tostandardsand manages multiple versions in line with adoption needs of the clinical trialsand drug development programs.
  • The CDSA provides the necessary support to the clinical programming teams to achieve consistent adoption of standards in the studies (internally or outsourced to a CRO). To that end, the CDSA pro-actively support identifying the standards supporting the trial objectives.
  • The CDSA tailorsthe global standards to the specific needs of Therapeutic Areas or Disease Ares,while maintaining the traceability and lineage of themetadata.The CDSA documentsand correctly manages the lineage between global standardsandthepre-configured (tailored) standards.
  • The CDSA provides the necessary support to the clinical programming teams to achieve consistent adoption of standards in the studies (internally or outsourced to a CRO). To that end, the CDSA pro-actively support identifying the standards supporting the trial objectives.
    • Interfaces – Primary/Other:
  • Primary interfaces: The clinical data standards team and the data acquisition experts and the data managers in the data management function and the clinical programmers.
  • Other Interfaces: Clinical Analysis Standards, the clinical team (statistician, physician, …), CDISC working groups.
    • Education and Experience Guidelines:
  • Experience with coding and running SAS programs is required
  • Knowledge of Rave eDC (Medidata Solutions)is a preferred
  • Expertise with CDISC standards: SDTM, Controlled terminology anddefine.xml.
  • Experience with SAS LSAF and Pinnacle 21 is a plus
  • BS/BA degree in life sciences or computer science orequivalent by work experience
  • 3years ofrelevantoperational experience in clinical data managementand standards
  • Relevant development experience in clinical data standardsis strongly preferred
  • Experience in prioritizing and managing multiple tasks simultaneously
  • Outstanding written and verbalcommunication skills in English
    • Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.

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