J&J Family of Companies Senior Technical Data Architect in Beerse, Belgium
Senior Technical Data Architect
Locations : UK (High Wycombe), NL (Archimedesweg), Belgium (Turnhoutseweg) or Ireland (Home Based)
The Pharmaceutical sector of Johnson & Johnson is now looking for a Senior Technical Data Architect.
At Janssen, part of Johnson & Johnson, Family of Companies, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information.
The position is primarily accountable for providing expertise and delivery in technical clinical data management activities, including, CRF technical development, data stream integrations, data model specifications and mapping (SDTM or other), data quality review and submission-ready tabulation packages. The position works together with the Global Data Managers to ensure the solutions are optimal to deliver the trial data content. Position requires minimal oversight.
Principle Responsibilities Include:
Translate protocol requirements into optimal data capture approaches. Oversee development of data transfer agreements with ancillary data vendors ensuring use of standards, fit-for purpose data models and transfer intervals. Provide specifications and mapping for data models to be used for quality review and for final data model (SDTM or other). Ensure quality review of datasets (e.g., Pinnacle 21 compliance checking); ensure datasets are available for stakeholder use (medical review, central monitoring, adaptive design, etc.) and compliant for Database lock and submission-ready tabulation packages.
Develop and maintain working knowledge and expertise in programming languages utilized in data management (SAS, SQL, etc.) and apply continuous learning as data management platforms evolve.
Bachelor’s degree or equivalent work experience and experience in data management (data review, database management, standards development, statistical or data management programming, CRF build, etc.).
The following competencies are required:
Knowledge of protocol and current clinical drug development processes
Knowledgeable of international guidelines regarding clinical trials end to end
Working knowledge of an eDC systems
SAS programming skills or other analytical programming language
Working knowledge of SDTM including Define.xml, CDASH, metadata and ADAM
Ability to work with cross-functional team interpreting data requirements.
Proven project management skills
Working knowledge of reporting tools, e.g. Spotfire a plus
Vendor management oversight experience a plus
United Kingdom-England-High Wycombe-
Europe/Middle East/Africa-Ireland, Belgium-Antwerp-Beerse, Netherlands-South Holland-Leiden
Janssen Cilag Ltd. (7360)
Clinical Data Management
J&J Family of Companies
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