Feb 12, 2024

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 role will be accountable for leading a team responsible for ensuring effective planning, delivery and oversight of user support and knowledge management activities in relation to clinical document management processes and systems across the Novartis organization.

Identifies, plans and drives implementation of CDGM initiatives, projects and process improvement activities to enhance clinical document management systems, processes and standards at Novartis.

The role can be based in either in Ireland, United Kingdom or India.

Major Accountabilities:
• Lead a team delivering user support related to clinical document management processes, adoption of Trial Master File (TMF) and good documentation practices across the business.
• Identifies, plans and drives implementation of CDGM initiatives, projects and process improvement activities to enhance clinical document management systems, processes and standards at Novartis.
• Act as CDGM contact for key stakeholders, collaborating with them to improve clinical documentation process, systems and capabilities across the organization.
• Delivers excellence in service delivery, including optimization and simplification in compliance with Novartis policies & regulatory requirements, responding in an agile way to new or evolving business priorities.
• Provide robust oversight of 3rd party vendor activities including monitoring sustainable performance against SLAs.
• Lead or contribute to cross functional initiatives or projects, including defining and gaining approval for projects or initiatives, and ensuring deliverables are achieved in line with agreed timeframes and budget.
• Embeds a risk-based mindset across the team and in service delivery, ensuring identification, evaluation and management of risks, including mitigation activities.
• Set priorities, manage schedules and develop robust resourcing model to support timely delivery of TMF services.
• Support CDGM and business teams in preparation for and during audits, inspections and migration activities. Own CAPAs arising from inspections/audits ensuring they are closed out on time.
• Leads team, recruits, retains, manages and develops associates through coaching and feedback, talent reviews and other available Novartis resources and tools, and fosters a safe environment for team dialogue and growth.


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

What you’ll bring to the role:
• Advanced degree or combination of Bachelor’s degree in life-sciences/healthcare/pharmacy and relevant industry experience
• English fluency (written, oral) required
• Minimum of 8 years of 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.
• Minimum of 3 years’ 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., DIA TMF reference model).
• Demonstrated success in planning and executing cross functional projects.
• Strong influencing and presentation skills. Ability to communicate effectively at all levels.
• Good organizational awareness, including experience working in multi-disciplinary teams, across cultures and geographies.
•Good negotiation, problem solving and conflict resolution skills; experience establishing trusted relationships with internal and external stakeholders.


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

Novartis Ireland Ltd. has been certified as a Top Employer 2022 by the Top Employers Institute for its exceptional employee offerings!

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 Process User Support Team Lead

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