Job Description

About the roleEvery 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 growing universe of data.We are seeking a CDM -Learning Manager to join our team and develop capability, learning and knowledge management activities related to the delivery of CDGM services and the adoption of TMF (Trial Master Files) and good documentation practices across the business.
This person will drive implementation of CDGM initiatives, projects, and process improvement activities to improve CDM systems, processes, and standards at Novartis.
Key Responsibilities:

• Accountable for capability and learning activities related to the delivery of CDGM services and the 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.
• Develop and implement effective, fit for purpose capability development, learning and knowledge management results to users of TMF and CDGM services across the business.
• Partner with key collaborators across the business to understand learning and knowledge management needs and proactively identify/implement solutions to meet those needs.
• Build and lead metrics/KPIs and dashboards relating to CDGM learning, capability and knowledge management activities and facilitate discussions with CDGM LT and others relating to trends and issues.
• Partner with service providers and internal collaborators to ensure 3rd party partners are aware of and delivering their services aligned with CDGM capability, learning and knowledge management requirements.
• Partner with learning, capability and knowledge management groups across Novartis to ensure CDGM are aligned with wider efforts, and to keep aware and leverage standard methodologies and new developments.
• Serve as an authority on TMF learning, formal and informal processes and tracking tools relating to learning, Associate development and knowledge management.
• Support the development and delivery of strategies to increase the adoption and improvement in TMF health and document management across customer groups.
• 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.

Role RequirementsRole Requirements :This role reports to the Head CDM Process.The role can be based in either in Ireland (Dublin hybrid) UK (home based), India (HYD hybrid). Please note relocation will not be provided.

• 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.
• Proven success in planning and driving 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 positive relationships with internal and external collaborators.

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-cultureYou\'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-rewardsCommitment 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/networkFunctional AreaResearch & DevelopmentDivisionDevelopmentBusiness UnitGCO GDDEmployment TypeRegularCommitment to Diversity & Inclusion:We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Shift WorkNoEarly TalentNo

Novartis