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 delivering user support related to clinical document management processes, adoption of TMF and good documentation practices across the business.

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:
· Support the development and delivery of fit for purpose end user support in relation to CDGM / TMF processes to Novartis business groups.
· Partner with stakeholders across the business to understand user needs and root causes of issues in relation to TMF and CDGM service delivery and proactively identify/implement improvements to end user support activities.
· Support for management of metrics/KPIs and dashboards relating to CDGM end user support and conduct data analysis to identify trends and issues.
· Serves as Subject Matter Expert on TMF training materials, formal and informal processes and tracking tools relating to end user support.
· Partner with service providers and internal stakeholders to ensure end user support provided by 3rd party partners is aligned with CDGM requirements, and embed assessment of end user support into oversight of third-party service performance.
· Support activities to increase CDGM staff capabilities in relation to end user support, and embed user-centric approaches into CDGM service delivery.
· Provide support in preparation for audits/inspections, contributes to root cause analysis identification and creation/delivery of CAPAs
· Act as CDGM point of contact for other projects and initiatives, to ensure engagement and involvement of CDGM as needed.


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:

• Bachelor’s degree or equivalent and relevant industry experience

• English fluency (written, oral) required

• Minimum of 5 years 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.
• Demonstrated success in planning and executing cross functional projects.
• Strong influencing and presentation skills. Ability to communicate effectively at all levels.
• High 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 Manager

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