Feb 12, 2024
United Kingdom

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

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

United Kingdom
Research & Development
Full Time
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Clinical Document Management Reference Model Manager

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