Mar 23, 2023

Job Description

100,000 and more!
That’s how many patients are treated in our studies. And every year, 3 million documents are uploaded in the electronic Trial Master Files to preserve the story of the study and ensure innovative medicines can reach even more patients worldwide.
But in this world of digital and technological transformation, we must also continue to evolve our approaches to clinical document management and unleash the power of information from this expanding universe of data.

Accountable for leading a CDM sub team, ensuring effective planning, delivery and oversight for a defined portfolio of CDGM services

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 and United Kingdom.

Major Accountabilities:

• Lead a team delivering user support related to clinical document management processes, adoption of 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.

Minimum 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.


You’ll receive:

Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.

Why consider Novartis?
769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn 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!
Global Drug Development
United Kingdom
Research & Development
Full Time
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CDM Process User Support Team Lead

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