Head, Clinical Document Management Integrated Systems Director

This position is a hybrid position based in Dublin. Novartis can not offer relocation for this position. Please only apply if the country location suits you.

Key responsibilities but not limited to:

• Drive the implementation of the clinical records management systems innovation roadmap including ML/AI and relevant interfaces in partnership with GCO’s Technology and AI, DDIT, QA and other relevant business functions
• Ensure efficient user support model for system related inquiries in a timely, efficient and resolutive manner
• Ensure effective business system ownership including maintenance of business rules, user requirements and metadata standards for digital data interoperability, transferability, reuse and preservation, and business administration (BA) activities
• Provide business leadership and support on GxP data/record migration and integration projects
• Foster thought leadership in the clinical operations tech space through proactive external network and industry associations (e.g. CDISC) contribution, keeping sight of evolving tech landscape; builds trusted relationships with internal Compliance and QA functions as well as Health Authorities inspectors
• Set, review and evaluate annual performance objectives for the team in alignment with company goals, establishes priorities and distribution of work, forecasts demand and resource needs and contributes to the CDGM budget cycles
• Recruit, retain, manage and develop associates through coaching and feedback, talent reviews and other available Novartis resources and tools
• Effective vendor management as demonstrated by SLA and KPIs vs budget and resources within 5% of cost overruns
• CDGM systems infrastructure compliant with Regulatory standards, GxP and expectations
• Significant contribution to building CDGM high performing team
• CDGM and travel budget accountability for own resources. Project and External budget accountability for provided services

Essential criteria:

• Advanced degree or combination of Bachelor’s degree in information or life-sciences/healthcare and relevant industry experience.
• Significant years experience working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organisations) with specific experience in clinical documentation and/or records & information management.
• Strong experience in direct people management or matrix management of project/clinical teams.
• Deep understanding of drug development process, international drug approval procedures and standards (e.g. ICH-E3, ICH-E6, eCTD) and industry-wide standards in clinical document management (e.g. CDISC TMF reference model).
• Demonstrated success in planning and executing cross functional change projects.
• Strong influencing and presentation skills. Ability to communicate effectively at all levels.
• High organisational awareness, including experience working in multi disciplinary teams, across cultures and geographies.
• Good negotiation, problem solving and conflict resolution skills; experience establishing trusted relationships with internal and external stakeholders.
• Good understanding of machine learning, automated workflows and artificial intelligence capabilities applied to records management is strongly desired.