Principal Clinical Data Standards Specialist

• Data collection tools in EDC (CRFs, edits checks, derivations, core configurations) and data transfer specifications
• Analysis data/TFL standards
• Associated standard metadata, business rules and guidelines.

1. Lead and contribute to Clinical Data Standards definition, development, validation and support within assigned standards discipline (domain) including the development and maintenance of associated metadata, documents, business rules and guidelines where applicable.

4. In collaboration with representatives across Data Operations disciplines and key stakeholder and partner functions within GDO and across Global Drug Development, ensure the accurate translation of scientific and analytical requirements into efficient, compliant standards.
5. Support and ensure the appropriate and efficient governance and approval of global and project/study specific clinical data standards liaising with governance boards as needed. 6. Contribute to the technical review and assessment of industry and regulatory standards and guidelines supporting regular gap/impact analysis and implementation of action plans where needed. 7. Communicate effectively with the partners and customers; Establish and maintain strong collaborative relationships with Data Operations, Biostatistics and Clinical Development groups supporting the development and use of Clinical Data Standards. 8. Lead and contribute to the development, maintenance and training of relevant clinical standards systems and processes.

9. Act as an expert consultant providing Clinical Data Standards input to all relevant areas including; electronic data capture/database programming, edit check programming, report programming, electronic data loads, IVR technology, electronic patient reported outcomes, metadata management and/or other clinical data management or analysis data and TFL-related systems

10. Act as subject matter expert (SME) for assigned area providing support, consultation and training to end users and SME networks on implementation of standards and related tools on development programs.
11. Provide mentoring and technical guidance to Clinical Data Standards associates. 12. Maintain up-to-date, expert knowledge of relevant technologies (EDC, software languages, applications etc.), Industry Standards (e.g. CDISC, define.xml, eCTD etc.) and regulatory guidelines. 13. May represent Novartis within industry wide associations and working groups; contributing to regulatory guidelines, industry practices and professional standards development organizations such as CDISC, CFAST, PhUSE CSS, DIA etc. 14. As needed, act as a Clinical Standards representative supporting data standards governance, process improvement initiatives and/or other non-clinical projects.

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