Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Clinical Data Architect â Data Collection & Delivery to be based in either Spring House PA, Horsham PA, Raritan NJ or Titusville NJ.
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. We pursue the most promising science, wherever it might be found.
We discover and develop innovative medical solutions to address unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Visit http://www.JanssenRnD.com to learn more
The job holder implements and maintains standard content in the data collection tools and in defines and maintains the standard metadata supporting the data flow from data collection to data delivery. The job holder is responsible for implementing efficient standards that cover all data capture tools and mechanisms and for the scientific and operational correctness of the collection and metadata standards in support of the R&D portfolio of drug development programs. This person configures standards to the specific needs and requirements of a Therapeutic Area, compound our Disease Area, generating the expected efficiencies through optimal adoption and reuse of standards. They also will support the functions adopting the standards in the clinical trials, in close collaboration with the clinical data collection team.
- To that end, the job holder works closely together with the clinical data collection standards team that facilitates the content definition of these standard data collection tools.
- Implements standard content in the collection tools compliant to the industry standards and health authority regulations, meeting best computer system validation practices where applicable. The job holder 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).
- Guarantees the correctness of the annotated case report form meeting submission, scientific and operational requirements and guidelines.
- Defines and maintains the standard clinical data collection -, data review - and data delivery metadata for use in clinical trials. The job holder also defines and maintains the standard mapping -, and derivation metadata used for automating the data flow from data collection tool (e.g. eCRF) to the Data Review Model (DRM) and from DRM to Study Data Tabulation Datasets (SDTM).
- Consults with the Clinical Data Collection Standards team for scientific correctness of the metadata, with the Clinical Data Analysis Standards team for guaranteeing the delivery metadata meet the analysis requirements and with the Standards Regulatory Intelligence team for the compliance of the metadata with industry regulations.
- Documents, implements and maintains scientifically and operationally correct traceability between domain and variable metadata across the different metadata models, regardless of the mechanism of collection. The job holder is also responsible for setting up the standard metadata compliant to the industry standards and health authority regulations.
- The job holder pre-configures the standards in line with the specifications of the data lifecycle plan, which documents the standard data collection, analysis and reporting strategy and content for a drug development programs, while maintaining the traceability and lineage of the data. The job holder documents and manages correctly the lineage between master standards and the many pre-configured standards.
- BS/BA degree in life sciences or computer science is required
- 2 years of relevant operational experience in clinical data management is required
- Relevant operational experience in clinical data standards is preferred
- Proven knowledge of good data management practices is required
- Experience with Clinical Data Management / Statistical Programming is preferred
- Experience with SAS based systems is required
- Experience with CDISC standards (SDTM, CDASH, define.xml, Etc.) is required
- Experience with prioritizing and managing multiple tasks simultaneously is required
Johnson & Johnson is an equal opportunity employer
United States-New Jersey-Titusville
North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)
Clinical Data Management
Click here for more info: https://jnjc.taleo.net/careersection/2/jobdetail.ftl?job=5699170801&lang=en
• Post ID: 43735878 southjersey