Company
pharmaceutical
Head,ClinicalDocumentManagementIntegratedSystems
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“Head, Clinical Document Management Integrated Systems. Skills: Clinical Document Management, Integrated Systems, AI/ML, Leadership, Strategy Development, Process Improvement. Drive the implementation of the clinical records management systems innovation roadmap including ML/AI and relevant interfaces. Ensure efficient user support model for system related inquiries”
What You'll Achieve.
Ensure efficient user support model; Ensure effective business system ownership; Achieve SLA and KPIs vs budget and resources within 5% of cost overruns; CDGM systems infrastructure compliant with Regulatory standards, GxP and expectations
Industry & Context.
Problem solving; Conflict resolution
Based in Dublin, No relocation offered, Travel budget accountability
What They're Looking For.
Must Have
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, 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, 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 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
Nice to Have
Good understanding of machine learning, automated workflows and artificial intelligence capabilities applied to records management
What You'll Do.
Drive the implementation of the clinical records management systems innovation roadmap including ML/AI and relevant interfaces
Ensure efficient user support model for system related inquiries
Ensure effective business system ownership including maintenance of business rules
user requirements and metadata standards
Provide business leadership and support on GxP data/record migration and integration projects
Foster thought leadership in the clinical operations tech space
review and evaluate annual performance objectives for the team
manage and develop associates
Ensure CDGM systems infrastructure compliant with Regulatory standards
Contribute to building CDGM high performing team
CDGM budget accountability
Project and External budget accountability
How You'll Work.
Team & Collaboration
Partnership with GCO’s Technology and AI, DDIT, QA and other relevant business functions; Working in multi disciplinary teams, across cultures and geographies; Establishing trusted relationships with internal and external stakeholders; Building CDGM high performing team
Communication Scope
Ability to communicate effectively at all levels; Presentation skills
Process & Methodology
Planning and executing cross functional change projects, Program Management
Full Job Description
**Job Description Summary** This position plays a critical leadership role in a complex matrix with all parts of the R&D organisation 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 for example for: the implementation and embedding of regulatory, safety and site document exchange mechanisms in a sustainable way of working and integration of these capabilities into future clinical TMF strategies; the integration of existing systems and functionalities with future direction including AI/ML, genAI and automated workflows; support Non-Interventional study information management needs; incorporating clinical information from external sources contributing to the conduct of studies (e.g. CROs, BD&L inlicensed partners) including processes and automation, integration of these 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. **Job Description** 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, r
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