Overview
This position plays a critical leadership role in a complex matrix with all parts of the R&D organization that contribute essential records for drug development and implement strategies that incorporate many systems that hold clinical trial data. The Head, Clinical Document Management Integrated Systems drives initiatives in the Clinical Document Management tech space, such as the implementation and embedding of regulatory, safety, and site document exchange mechanisms, sustainable ways of working, and integration of these capabilities into future clinical TMF strategies. It also involves integration of existing systems and functionalities with future direction, including AI/ML, genAI, and automated workflows; support for non-interventional study information management needs; and incorporation of clinical information from external sources that contribute to the conduct of studies (e.g., CROs, BD&L inlicensed partners), including processes and automation and integration into the TMF strategies. You would also be responsible for designing and developing new business processes and strategies while proactively identifying business risks and proposing and implementing strategies to manage the implications of these risks on the business.
Location
This position is a home worker / hybrid position based in the UK. Novartis cannot offer relocation for this position. Please only apply if the country location suits you.
Key Responsibilities
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 multidisciplinary 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.
Benefits
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