Johnson & Johnson Careers
Manager, Data Standards Delivery Architect
Requisition ID: 1385190405
The clinical data delivery standards architect is responsible for developing and maintaining standards that enable the data management and data delivery processes in Janssen clinical trials. To that end, the clinical data delivery standards architect owns the standards, the related metadata and the tools used for standards development, maintenance and consumption. The clinical data delivery standards architect is also a critical contributor to the implementation a fully metadata driven process from data collection to data delivery. The clinical data delivery standards architect defines and implements standard strategies for automating clinical trial data flow processes from collection to delivery by maximizing the value of metadata as operational data in the clinical trial process.
This position works closely with clinical data management, statistical programming, clinical operations and information technology functions. This position requires the ability to think holistically to help identify opportunities and shape solutions meeting clinical trial objectives.
- Responsible for implementing efficient standards covering all data capture and delivery tools and mechanisms, for scientific and operational correctness of the metadata standards in support of the Janssen R&D portfolio of drug development programs.
- Responsible for implementing efficient data delivery metadata standards (e.g. SDTM) and mapping metadata standards from data collection to data delivery generating a high level of automation in the study setup processes and resulting in early access to clinical data.
- Drives the process of shaping metadata standards by influencing key stakeholders, such as clinical data managers, technical data managers and statistical programmers to align with the standards organization’s strategy and objectives.
- Configures standards to the specific needs and requirements of a therapeutic area, compound or disease area while maximizing the reusability of the standards across the therapeutic areas.
- Partners with key stakeholders, serves as primary standards contact for the various functions, and works with stakeholders to capture and translate requirements for data standards achieving a high level of efficiency and automation in Janssen clinical studies.
- Develops deep expertise in industry standards related to data collection and delivery such as Clinical Data Acquisition Standards Harmonization (CDASH), Study Data Tabulation Model (SDTM), Controlled Terminologies (CT) and, if needed, Therapeutic Area User Guides (TAUG) and in metadata standards such as ISO 11179 or other standards such as HL7 - Fast Healthcare Interoperability Resources (FIHR).
- The job holder develops and implements strategies to leverage existing externally available metadata repositories. The job holder evaluates the value of integrating these external metadata repositories into the Janssen environment and will develop the approach for integration and usage of these repositories. Examples are the CDISC Library with foundational and therapeutic area standards and NCI’s Cancer Data Standards Registry and Repository (caDSR).
- Proactive in exploring and implementing solutions for automating the data flow from collection and delivery through a fully metadata standards driven process. The job holder explores and implements biomedical concepts which will generate efficiencies and consistency across the data flow.
- Future looking, the job holder will take a leadership role in evaluating, piloting and implementing new solutions that will result in advanced development, implementation and adoption of standards and that will pave the way to a high degree of interoperability between Janssen Research and Development, partner companies such as CROs, central labs and other third-party data or service providers.
- Proactive in exploring and implementing solutions for alternative trial designs such as platform trials, pragmatic trials and direct-to-patient trials, for digital health tools collecting data from wearables (mHealth) and collecting real world data (RWD) and for integration with eHR/EMR systems.
- BS/BA degree, MS degree preferred, in life sciences or computer sciences, or equivalent by work experience
- 7 years of relevant experience in pharmaceutical industry is required
- Experience with metadata, metadata repositories and metadata driven processes is required.
- Knowledge of - and experience with CDISC SDTM standard is required
- Knowledge of ISO 11179 standards is a plus
- Experience with Rave eDC is a plus
- Experience with semantic technologies such as RDF, OWL, SPARQL or graph databases is a plus
- Entrepreneurial spirit, excited exploring new but unknown avenues
- Innovational spirit, proven record of translating an idea into a solution that creates value
- Experience with Clinical Data Management / Statistical Programming
- Experience in prioritizing and managing multiple tasks simultaneously.
- Outstanding written and verbal communication skills in English
United States-New Jersey-Titusville-
Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, United States-New Jersey-Raritan, United States-Pennsylvania-Spring House, Netherlands-South Holland-Leiden
Janssen Research & Development, LLC. (6084)
Clinical Data Management