Yacht Life Sciences has a vacancy for a Clinical Data Standards Architect (Data Collection) at Janssen Biologics in Leiden.
The Clinical Data Standards Architect (CDSA) - Data Collection implements and maintains 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.
The CDSA defines and maintains the standard collection metadata supporting the data flow from data collection to data delivery (SDTM). To that end the CDSA is responsible for defining and maintaining the metadata supporting the CRF and consulting with the CDSA responsible for data delivery metadata (SDTM) for compliance with the SDTM standard.
The CDSA configures 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. The CDSA also supports the functions adopting the standards in the clinical trials
The CDSA is responsible for collaborating with an external service provider implementing efficient standards in the Rave eDC system (Medidata Solutions) and guaranteeing quality.
• The CDSA defines 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. Examples
o Standard Case Report Form Mockups
o Standard Questionnaires, Rating Scales and Clinical Outcome Assessments
o Standard Validation Rule Specifications
o Standard Integrations (e.g. with IWRS)
• The CDSA implements standard content in the collection 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 collection tools and therefore collaborates with the respective functions in Integrated Data Analysis and Reporting (IDAR).
• The CDSA defines and maintains the clinical data collection standards in line with the needs in clinical trials to meet additional scientific or operational requirement. 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 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 data management 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
• Other Interfaces: Clinical Analysis Standards, the clinical team (statistician, physician, …), CDISC working groups.
• Finished 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
• Experience with running SAS programs, coding experience preferred.
• Deep expertise in Rave eDC (Medidata Solutions)
• Expertise with CDISC standards: SDTM, CDASH and Controlled terminology is required
• Experience with SAS LSAF and Pinnacle 21 is a plus
• Working remotely
- Strong communication skills
- Experience in prioritizing and managing multiple tasks simultaneously
- Outstanding written and verbal communication skills in English
Terms of employment:
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.
Information about the company:
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.
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.