363919BR
Mar 19, 2024
United Kingdom
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 Technology Business Data Specialist provides data knowledge and analysis capabilities to support Novartis enterprise-wide clinical electronic document management systems (eDMS) and related migration activities, partnering with technical vendors, internal IT and business stakeholders, aligned with business, regulatory and IT requirements.
Drives implementation of CDGM initiatives, projects and process improvement activities to enhance the management of enterprise clinical eDMS at Novartis
The CDM Technology Business Data Specialist provides data knowledge and analysis capabilities to support Novartis enterprise-wide clinical electronic document management systems (eDMS) and related migration activities, partnering with technical vendors, internal IT and business stakeholders, aligned with business, regulatory and IT requirements.
Drives implementation of CDGM initiatives, projects and process improvement activities to enhance the management of enterprise clinical eDMS at Novartis
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 UK, Ireland or India.
Our selection process will prioritize associates whose roles may be changing or may be impacted
• Bachelor’s degree or equivalent 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.
• Strong understanding of data structures related to electronic document management systems, specifically latest trends and knowledge of Veeva Clinical Vault, RIM
• 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 Electronic and Clinical Document Management systems and features
• Deep knowledge of Agile way of working with cross functional teams for data interfaces and releases
• 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.
For UK:
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.
(Ireland/India packages as per local guidelines)
Why consider Novartis?
743 million. 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!
For the Ninth consecutive year, Novartis been certified a ‘Top Employer’ in the UK (2014-2022)!
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
We are Novartis. Join us and help reimagine medicine.
#GCO
#CDGM
Our selection process will prioritize associates whose roles may be changing or may be impacted
• Bachelor’s degree or equivalent 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.
• Strong understanding of data structures related to electronic document management systems, specifically latest trends and knowledge of Veeva Clinical Vault, RIM
• 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 Electronic and Clinical Document Management systems and features
• Deep knowledge of Agile way of working with cross functional teams for data interfaces and releases
• 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.
For UK:
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.
(Ireland/India packages as per local guidelines)
Why consider Novartis?
743 million. 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!
For the Ninth consecutive year, Novartis been certified a ‘Top Employer’ in the UK (2014-2022)!
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
We are Novartis. Join us and help reimagine medicine.
#GCO
#CDGM
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
Development
GCO GDD
United Kingdom
National
Novartis Pharmaceuticals UK Lt
Ireland
India
Research & Development
Full Time
Regular
No
