Mar 19, 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.

The CDM Migration Business Lead is responsible for effective planning and delivery of migrations to and from of Novartis enterprise-wide clinical electronic document management systems (eDMS) aligned to Novartis business needs, partnering with technical vendors, internal IT and business stakeholders.

Drives implementation of CDGM initiatives, projects and process improvement activities to enhance the planning and execution of migrations to and from enterprise clinical eDMS at Novartis.

Act as CDGM point of contact for partnering with CDGM, IT (internal and external) and business stakeholders to plan and execute migrations to and from eDMS, in line with Novartis business, compliance and operational requirements.

Partner with CDGM and business stakeholders, especially those planning in-licensing and out-licensing activities to identify and agree migration business requirements, understand source and target system capabilities and develop/maintain a future migration roadmap.

Contribute to activities to ensure efficient processes & integrations of systems with eDMS based on strong understanding of Novartis enterprise systems landscape and in line with compliance and business priorities. Serves as Subject Matter Expert for training materials, formal and informal processes and tracking tools for eDMS migration activities, in collaboration with CDM Process team and other key stakeholders

Plan and contribute to agile working methodologies being applied during development cycles to prepare for migration and during post migration hyper care period.

Owner or Contributor of activities related to migration related Incident Management, Change Management and ongoing operations of the eDMS.

Support forecasting of internal resource allocations and vendor provided activities as part of eDMS migration roadmap management.

Executes vendor oversight plan, monitors service metrics and identifies opportunities for improvement to the operating model in relation to migration. Acts as point of escalation for issues.

Provides support for inspections/audits, contributes to root cause analysis identification and creation/delivery of CAPAs.

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

The role can be based in either Ireland, India, Switzerland or UK.
Our selection process will prioritize associates whose roles may be changing or may be impacted

• Advanced degree or combination of Bachelor’s degree in information or life-sciences/healthcare and relevant industry experience. Minimum of 6 years working in Pharmaceuticals, Lifesciences and Clinical Research with specific experience in contributing and leading of clinical document management, TMF and/or records & information management.
• Minimum of 5 years of full-scale migrations
• Minimum 2 medium to major Veeva related hands-on and provable experience in leading and planning of migrations.
• Prior experience in Electronic Document Management systems, specifically in Clinical and Regulatory highly desired.
• Business relevant technical and working experience of eDMS systems like Veeva Clinical vault, RIM, Documentum D2LS or similar
• Knowledge of industrywide Electonic and Clinical Document Management systems and features
• Deep knowledge of Agile way of working with cross functional teams for releases
• Strong influencing and presentation skills. Ability to communicate effectively at all levels

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.

*Applicable for Ireland, may vary in Switzerland, India or UK.

Why consider Novartis?
236million. That’s how many lives our products touched in 2022. 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!


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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CDM Migration Business Lead

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