Summary
About the Role
Your responsibilities include, but are not limited to:
• Lead and contribute to Clinical Data Standards planning, 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.
• Serves as the primary contact for global data acquisition and tabulation, analysis or data submission standards for core global and/or assigned Therapeutic Area ensuring timely and quality deliverables.
• Define and deliver to robust, priority driven standards development plans for assigned area to ensure agreed deliverables are met and assigned resources are fully and effectively utilized.
• Accountable for driving the efficient, high quality and timely implementation of new standards and/or updates to standards; In collaboration with representatives across Data Operations disciplines and key stakeholder and partner functions within GDO and across Global Drug Development, lead the accurate translation of scientific and analytical requirements into efficient, compliant standards.
• 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.
• Lead the technical review and assessment of industry and regulatory standards and guidelines supporting regular gap/impact analysis and implementation of action plans where needed.
• 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.
• Lead and contribute to the development, maintenance and training of relevant clinical standards systems and processes. 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.
Role Requirements:
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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