About the Role
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 CDM and unleash the power of information from this growing 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.
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The role reports to the Head CDM Process and can be based in either in Ireland, the United Kingdom or India.
Key responsibilities:
• Support the development and delivery of fit for purpose end user support in relation to CDGM / TMF processes to Novartis business groups.
• Partner with collaborators 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 an authority on TMF training materials, formal and informal processes and tracking tools relating to end user support.
• Partner with service providers and internal collaborators 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
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
Role Requirements :
What you'll bring to the role:
• Bachelor's degree or equivalent and relevant industry experience
• Minimum of 5 years working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organizations) with specific experience in clinical documentation and/or records & information management.
• Demonstrated success in planning and driving multi-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 positive relationships with internal and external partners.
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
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
Division
Development
Business Unit
GCO GDD
Location
United Kingdom
Site
National
Company / Legal Entity
Novartis Pharmaceuticals UK Lt
Alternative Location 1
Ireland
Alternative Location 2
India
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No