Mar 06, 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 Process & Standards Manager is individual contributor role is accountable for developing and implementing effective processes and standards for clinical document management at Novartis, drive the adoption of good documentation practices collaborating with cross-functional teams globally.

The role can be based in either in Dublin, United Kingdom (remote) or Hyderabad/Mumbai.

Major responsibilities:
Your responsibilities include, but are not limited to:
· Provide oversight of CDGM-owned processes and standards, their version control and associated organisational impact and training requirements.
· Create and maintain effective formal and informal processes (e.g., standard operating procedures, work instructions, guidance documents) and standards (e.g., templates, forms, job aids, process maps) for clinical document management in alignment with the Novartis quality management framework and process governance review boards. This also includes partnering with document management service providers to develop fit for purpose written standards (e.g., operations manuals, process maps) that enable robust oversight of third-party service performance.
· Contribute to the Novartis Reference Model standard, providing subject matter expertise and guidance on essential documents lists, business rules on taxonomy and metadata specifications for system configuration, in close partnership with CDM Technology and Line Function representatives owning processes that result in such essential documents.
· Contribute to the process improvement initiatives to drive the adoption and improvement in TMF health, ALCOA CCEA and good document management across stakeholder groups.
· Provide support in preparation for audits/inspections, contributes to root cause analysis identification and creation/delivery of CAPAs in relation to clinical document management processes and 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

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 organisational awareness, including experience collaborating with multi-disciplinary teams, across cultures and geographies.
• Good negotiation, problem solving and conflict resolution skills; experience establishing trusted relationships with internal and external stakeholders.
• In-depth knowledge of formal and informal process design/writing in simple, clear, and concise manner.
• Experience with LEAN/Six Sigma, experience with quality management systems and standards is a plus.


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 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

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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Clinical Document Management Process & Standards Manager

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