Company
pharmaceutical
Head,ClinicalDocumentManagementIntegratedSystems
Neural analysis suggests this role is
optimal for Senior candidates.
“Head, Clinical Document Management Integrated Systems. Skills: Clinical Document Management, Integrated Systems, AI/ML, Leadership, Strategy Development, Change Management. 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.
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.; Contributes to the CDGM budget cycles.; 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.
Industry & Context.
Problem solving experience.; Conflict resolution experience.
Hybrid position based in Dublin., Novartis can not offer relocation for this position., Only apply if the country location suits you.
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.
Nice to Have
Good understanding of machine learning, automated workflows and artificial intelligence capabilities applied to records management is strongly desired.
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.
Manage vendor performance.
Ensure CDGM systems infrastructure compliant with Regulatory standards
GxP and expectations.
Contribute to building CDGM high performing team.
Accountability for CDGM and travel budget.
Accountability for Project and External budget for provided services.
How You'll Work.
Team & Collaboration
Partnership with GCO’s Technology and AI, DDIT, QA and other relevant business functions.; Building trusted relationships with internal Compliance and QA functions as well as Health Authorities inspectors.; Working in multi disciplinary teams, across cultures and geographies.
Communication Scope
Ability to communicate effectively at all levels.; Presentation skills.
Process & Methodology
Planning and executing cross functional change projects., Matrix management of project/clinical teams.
Full Job Description
**Band** Level 6 **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, t
Applying for this Head, Clinical Document Management Integrated Systems role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about this company?
Real rants from real employees. Read before you apply.