Résumé
Accountable for delivering user support related to clinical document management processes, adoption of Trial Master File (TMF) and good documentation practices across the business. Drives implementation of Clinical Document Governance Management (CDGM) initiatives, projects, and process improvement activities to enhance clinical document management systems, processes, and standards at Novartis.
This is a hybrid role and can be based in Dublin or London offices. The expectation is to be in the office 12 days/month.
About the Role
Your responsibilities include, but are not limited to:
- 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.
Minimum requirements
- 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 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 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.
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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
