Clinical Data Architect

  • Salary: Competitive
  • REF Number: 00050750
  • Consultant: Jocelyn Blackham
  • Contact: 0041 (0) 800 106 106
  • Date Published: 01.06.2021
  • Sector: Basel Area
  • Location: Remote, Experienced
  • Discipline: Clinical - Data Management

Jocelyn Blackham is recruiting for a Clinical Data Standards Architect (CDSA) to join a leading global pharmaceutical company on a contract basis, until the end of the year, with a very strong possibility of extension. This role can be remote from anywhere in Europe.

The main purpose of the role will be to:

  • Implement and maintain efficient standard content in the data delivery tools (SAS, LSAF Excel based libraries) that can be applied across all the diseases areas and therapeutic areas orthat are specific to a specific therapeutic are or disease area.
  • Define and maintain the standard delivery metadata supporting the data flow from data collection to data delivery (DRM and SDTM)
  • Define and maintain 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 SDTM

Further responsibilities will include:

  • Correct testing and QC of the mappingmetadata and therefore collaborates with the respective functions in Integrated Data Analysis and Reporting (IDAR)
  • Annotating the eCRF or eCOA with SDTM metadata and collaborates with his/her team members on the correctness of the annotated casereport form meeting submission, scientific and operational requirements, and guidelines

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • 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 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
  • 3 years of relevant operational experience in clinical data management and standards
  • Relevant development experience in clinical data standards is strongly preferred
  • Experiencein prioritizing and managing multiple tasks simultaneously
  • Outstanding written and verbal communication skills in English

This is an excellent opportunity to join a global pharmaceutical organisation

For more information or to apply forthis position, please contact Jocelyn Blackham on 0041 (0) 800 106 106 or email jblackham@ckqls.ch. Please could you send any correspondence in English. Please quote reference 50750 in all correspondence.

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