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Clinical Document Management Reference Model Manager
Clinical Document Management Reference Model Manager-March 2024
Larkhall
Mar 17, 2025
ABOUT NOVARTIS
At Novartis, we’re reimagining medicine to improve people’s lives through innovative science and technology.
10,000+ employees
Biotechnology
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About Clinical Document Management Reference Model Manager

  About the Role

  Clinical Document Governance Management (CDGM) is accountable for strategy and delivery of clinical document management (CDM) systems, processes, standards and operations of CDM services (including Trial Master File management (TMF), clinical submission readiness, record retention and archiving, Good Documentation Practice capability build) across Novartis globally. In addition, CDGM is driving the transformation of TMF at Novartis, through the introduction and adoption of new technologies, processes and ways of working.

  This individual contributor role is accountable for the implementation of the governance framework to lead Novartis Clinical Document Management (CDM) Reference Model standards, including document taxonomy and metadata guidance, and to drive their adoption across the business and system configuration.

  The role can be based in either in Dublin or United Kingdom.

  Major responsibilities

  Your responsibilities include, but are not limited to:

  • Set up and maintain Novartis CDM Reference Model management framework partnering with key business and technology collaborators to ensure effective controls of crucial documents lists, taxonomy and metadata management across multiple systems and processes.

  • Lead the CDM Reference Model governance board, providing structure and process around it, facilitating effective decision-making and arbitrating across subject matter experts in multiple teams and line functions creating/owning document content.

  • Support the development and delivery of strategies to increase the adoption and improvement in TMF health and document management across collaborator groups through the effective implementation of Reference standards, and contribution to filing guidance, learning material and templates.

  • Provide support in preparation for audits/inspections, contributes to root cause analysis identification and creation/delivery of CAPAs in relation to Reference Model standards.

  Diversity & Inclusion / EEO

  Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

  Role Requirements

  Minimum requirements:

  What you'll bring to the role:

  • Bachelor's degree or equivalent and relevant industry experience

  • Minimum of 5 years working in bio-pharmaceutical clinical research and development with specific experience in clinical operations processes and clinical systems data interoperability.

  • In-depth knowledge of the TMF Reference Model, EDMS reference model, and other data governance standards.

  • Demonstrated success in running cross functional initiatives, facilitating governance boards and/or leading matrixed teams.

  • 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.

  Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

  You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

  Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

  Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

  Division

  Development

  Business Unit

  GCO GDD

  Location

  United Kingdom

  Site

  National

  Company / Legal Entity

  Novartis Pharmaceuticals UK Lt

  Alternative Location 1

  Ireland

  Functional Area

  Research & Development

  Job Type

  Full Time

  Employment Type

  Regular

  Shift Work

  No

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