CLS Services

Gepubliceerd: 18 dagen geleden

Clinical Data Standards Architect - Data Delivery

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Gepubliceerd: 18 dagen geleden
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CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Janssen Biologics B.V., we are searching for a Clinical Data Standards Architect - Data Delivery.

Keywords

  • B.Sc. life/computer sciences;
  • Clinical data management;
  • Coding and running SAS programs;
  • CDISC standards.

Job description
As Clinical Data Standards Architect (CDSA) - Data Delivery, you are responsible for the implementation and maintenance of 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.
Other responsibilities are:
  • Define and maintain the standard delivery metadata supporting the data flow from data collection to data delivery (DRM and SDTM). To that end, you are 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;
  • Configure 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;
  • Support the functions adopting the standards in the clinical trials, in close collaboration with the CDSA responsible for the data collection standards.


Deliverables:
  • Implement 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 (i.e. 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);
  • Implement standard content in the delivery tools compliant to the industry standards and health authority regulations, meeting best practices in computer system validation, where applicable;
  • Correct testing and QC of the mapping metadata and therefore collaborates with the respective functions in Integrated Data Analysis and Reporting (IDAR);
  • Annotate the eCRF or eCOA with SDTM metadata and collaborate with your team members on the correctness of the annotated case report form meeting submission, scientific and operational requirements, and guidelines;
  • Define and maintain the clinical data delivery standards in line with the needs in clinical trials to meet additional scientific or operational requirements. To that end, you will guarantee that formal change management control and versioning of the standards is applied and adhered to;
  • Formally govern all the changes to standards and manages multiple versions in line with adoption needs of the clinical trials and drug development programs;
  • Provide the necessary support to the clinical programming teams to achieve consistent adoption of standards in the studies (internally or out sourced to a CRO). To that end, you proactively support identifying the standards supporting the trial objectives;
  • Tailor the global standards to the specific needs of Therapeutic Areas or Disease Ares, while maintaining the traceability and lineage of the metadata. Document and correctly manage the lineage between global standards and the pre-configured (tailored) standards.


Who we're looking for
The ideal candidate has a B.Sc. in life sciences or computer sciences with at least 3 years of relevant operational experience in clinical data management and standards. You have experience with coding and running SAS programs and you have expertise in CDISC standards: SDTM, Controlled terminology and define.xml. Knowledge of Rave eDC (Medidata Solutions), experience with SAS LSAF and Pinnacle 21 and relevant development experience in clinical data standards is highly advantageous.

Company profile
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.



Additional vacancy information
Reference: A2100120
Contract: Temporary contract with CLS Services
Education: HBO/BSc.
Terms: Salary: >4350
Days of leave: 25 + 11
See here our other employment terms for this vacancy
Contactperson: Aniek Vugts
Phone: +31 (0)88 22 77 555

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Fulltime / parttime

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