Clinical Data Standards Architect (Yacht Life Sciences)

Janssen Biologics B.V.
  • Leiden
  • Detachering
  • HBO, WO
  • 40 uur
  • Thuiswerken mogelijk
Edwin Parlevliet avatar
Edwin Parlevliet principal recruitment consultant

Yacht Life Sciences has a vacancy for a Clinical Data Standards Architect at Janssen Biologics in Leiden.

The Clinical Data Standards Architect (CDSA)- Data Delivery implements and maintains 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 or that are specific to a specific therapeutic are or disease area.

The CDSA defines and maintains the standard delivery metadata supporting the data flow from data collection to data delivery (DRM 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 SDTM.

The CDSA configures standards to the specific needs and requirements of a Therapeutic Area, compound, or 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 CDSA responsible for the data collection standards.

Deliverables:

  • The CDSA implements the standard 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:

o Study Data Tabulation Model (SDTM)

o Annotated Case Report Forms (CRFs)

o Support the data transfer agreement (DTA) standards with SDTM

o Data Review Model (DRM)

o Mapping metadata from data collection (CRF and DTA) to DRM

o Mapping metadata from DRM to SDTM

  • The CDSA implements standard content in the delivery tools compliant to the industry standards and health authority regulations, meeting best practices in computer system validation, where applicable.
  • The CDSA is responsible for the correct testing 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 the correctness of the annotated case report form meeting submission, scientific and operational requirements, and guidelines.
  • The CDSA defines and maintains the clinical data delivery standards in line with the needs in clinical trials to meet additional scientific or operational requirements. To that end the CDSA will guarantee that 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 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 tailors the global standards to the specific needs of Therapeutic Areas or Disease Ares, while maintaining the traceability and lineage of the metadata. The CDSA documents and correctly manages the lineage between global standards and the pre-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.

Functie-eisen

  • Finished Bachelor 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
  • 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
  • Fluency in English
  • Working remotely

Competenties

  • Strong communication skills
  • Experience in prioritizing and managing multiple tasks simultaneously

Arbeidsvoorwaarden

This concerns a secondment contract via Yacht for 1 year (extension is possible). Full-time (40h) is strongly preferred, working 32 or 36 hours per week can be discussed. We will offer a competitive benefits package in line with your seniority and the seniority of the position (salary between 3800 and 6000 euro gross per 4-week period). You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.

Bedrijfsinformatie

Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.

Solliciteren

Inclusiviteit en diversiteit

Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.

Edwin Parlevliet avatar
Edwin Parlevliet principal recruitment consultant

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recruiter Edwin Parlevliet

Edwin Parlevliet

principal recruitment consultant

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