Clinical Data Standards Architect - Data Collection

Vacaturenummer: A2100124
Janssen Biologics B.V. - Leiden (Nederland)

For our client, Janssen Biologics B.V., we are looking for a Clinical Data Standards Architect - Data Collection.

Keywords

  • B.Sc. life/computer sciences;
  • Clinical data management;
  • Rave eDC;
  • SAS.


Profile
As Clinical Data Standards Architect (CDSA) - Data Collection, you are responsible for the implementation and maintenance of efficient standard content specifications for the data collection tools (eCRF and eCOA) 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 collection metadata supporting the data flow from data collection (CRF) to data delivery (SDTM). To that end, you will be consulting with the CDSA responsible for data delivery metadata (SDTM) for compliance with the SDTM standard;
  • Configure standards to the specific needs and requirements of a Therapeutic Area, compound, or Disease Area (fit for purpose), generating the expected efficiencies through optimal adoption and reuse of standards;
  • Support the functions adopting the standards in the clinical trials;
  • Collaborate with an external service provider implementing efficient standards in the Rave eDC system (Medidata Solutions) and guaranteeing quality.
Deliverables:
  • Define the specification of standard content in the data collections tools, primarily Medidata Rave, 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 (i.e. Standard Case Report Form Mockups, Standard Questionnaires, Rating Scales and Clinical Outcome Assessments, Standard Validation Rule Specifications and Standard Integrations (e.g. with IWRS) ).
  • Implement standard content in the collection 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 collection tools and, therefore, collaborate with the respective functions in Integrated Data Analysis and Reporting (IDAR); 
  • Define and maintain the clinical data collection standards in line with the needs in clinical trials to meet additional scientific or operational requirement. 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 manage multiple versions in line with adoption needs of the clinical trials and drug development programs;
  • 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;   
  • Provide the necessary support to the clinical data management 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.


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 deep expertise in Rave eDC (Medidata Solutions) and experience with running SAS programs, coding experience preferred. Expertise with CDISC standards: SDTM, CDASH and Controlled terminology is required. Experience with SAS LSAF, Pinnacle 21 and relevant development experience in clinical data standards is strongly preferred.

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:A2100124
Contract:Temporary contract with CLS Services
Education:HBO/BSc.
Employment terms:Salary: >4350
Days of leave: 25 + 11
See here our other employment terms for this vacancy
Publication date:7-6-2021
Location:View location with Google Maps
Contactperson:Claudia Erwich-Faaij
+31 (0)88 22 77 555

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