Manager, Data Collection Standards Architect

Johnson & Johnson Titusville , NJ 08560

Posted 1 week ago

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.

The Clinical Data Collection Standards Architect is responsible for developing and maintaining standards that enable the data collection processes in Janssen clinical trials. To that end, the Clinical Data Collection Standards Architect owns the eDC standards and the related collection and extraction metadata and the tools used for standards development, maintenance and consumption. The Clinical Data Collection Standards Architect is also a critical contributor to the implementation a fully metadata driven process from data collection to data delivery.

This position works closely with the clinical team, including study responsible physicians, clinical data managers, biostatisticians, statistical programmers and clinical operations. This position requires to think holistically, to influence and to facilitate a process of shaping collection standards that meet the clinical trial objectives and the standards organization's strategy and objectives.

Principle Responsibilities

  • Responsible for implementing efficient standards covering all standard eDC tools and for scientific and operational correctness of the collection and related metadata standards in support of the Janssen R&D portfolio of drug development programs.

  • Responsible for implementing efficient eDC libraries with related metadata standards generating a high level of automation in the study setup processes through reusability. To that end, the job holder provides clear specifications to a partner company that builds and maintains the actual eDC libraries. The job holder is responsible for overseeing the work at the partner company, including the validation of the eCRF library and is responsible for the final acceptance of the eCRF library.

  • Drives the strategy at a therapeutic area / drug development program / compound level to shape eDC and related standards that will enable the clinical studies with efficient and high-quality collection standards that meet the standards organization's vision and strategy.

  • Configures collection 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.

  • Drives the process of shaping collection standards by influencing key stakeholders, such as study responsible physicians, clinical data managers and biostatisticians to align with the standards organization's strategy and objectives.

  • Works pro-actively with the data management function in planning the studies and the adoption of the standards. Will actively support the correct implementation of the standards in the studies. Is responsible for following up after study-build and identifying areas for improvement, if any.

  • 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).

  • Proactive in exploring and implementing solutions for automating the study build and the data flow from collection and delivery through a fully metadata standards driven process. The job holder explores and implements biomedical concepts which can generate efficiencies and consistency in the data capture tools.The Clinical Data Collection Standards Architect is responsible for developing and maintaining standards that enable the data collection processes in Janssen clinical trials. To that end, the Clinical Data Collection Standards Architect owns the eDC standards and the related collection and extraction metadata and the tools used for standards development, maintenance and consumption. The Clinical Data Collection Standards Architect is also a critical contributor to the implementation a fully metadata driven process from data collection to data delivery.

  • 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, Health Authorities, 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 and for digital health tools collecting data from wearables (mHealth) and collecting real world data (RWD) and for integration with eHR/EMR systems.

Qualifications

  • 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 eDC tools, preferably Medidata Rave, is required

  • Knowledge of - and experience with CDISC CDASH and SDTM standard is required

  • Experience with metadata and metadata driven processes is highly appreciated.

  • Experience with semantic technologies such as RDF, OWL, SPARQL or graph databases is a plus

  • Entrepreneurial spirit, excited exploring new but unknown avenues

  • Proven record of leadership by influence

  • Innovational spirit, proven record of translating an idea into a solution that creates value

  • Experience in prioritizing and managing multiple tasks simultaneously.

  • Outstanding written and verbal communication skills in English

Primary Location

United States-New Jersey-Titusville-

Other Locations

Europe/Middle East/Africa-Netherlands-South Holland-Leiden, 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

Organization

Janssen Research & Development, LLC. (6084)

Job Function

Clinical Data Management

Requisition ID
1460190405


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Manager, Data Collection Standards Architect

Johnson & Johnson