384238BR
Jan 15, 2024
Ireland
About the Role
Location: Please note that this position can be based in the UK as a home worker or Dublin, Ireland as a Hybrid position.
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 Team Lead is accountable for effective planning, delivery and operational oversight of Clinical Document Management and Interfacing systems used for management of clinical documents required for regulatory submissions to ensure rapid, accurate and timely submissions to health authorities.
Your responsibilities include, but are not limited to:
Drives CDGM pivotal initiatives related to implementation, operations and business administrative support for enterprise document management systems (eDMS) to manage Clinical Documents originating from Clinical Trials.
Partners effectively with multi-functional stakeholders (e.g., Regulatory Affairs, Quality) to ensure eDMS are managed, updated and operated in agreed strategy and timelines to ensure seamless availability
Lead and be active contributor and owner of activities related to Incident Management, Change Management and ongoing operations of the eDMS
Lead internal resource allocations and oversight for vendors delivering eDMS services
Lead a high performing Business Administration team supporting 24/7 operations to ensure continuous and timely availability of CDM content for global business users
Recruits, retains, manages and develops associates through coaching and feedback, talent reviews, and managing performance.
Key member of cross-functional teams on business process, performance or system enhancement initiatives focused on Document Management systems used by Clinical and Regulatory Affairs teams, as required & support CDGM and business teams in preparation for and during audits & inspections.
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 Team Lead is accountable for effective planning, delivery and operational oversight of Clinical Document Management and Interfacing systems used for management of clinical documents required for regulatory submissions to ensure rapid, accurate and timely submissions to health authorities.
Your responsibilities include, but are not limited to:
Drives CDGM pivotal initiatives related to implementation, operations and business administrative support for enterprise document management systems (eDMS) to manage Clinical Documents originating from Clinical Trials.
Partners effectively with multi-functional stakeholders (e.g., Regulatory Affairs, Quality) to ensure eDMS are managed, updated and operated in agreed strategy and timelines to ensure seamless availability
Lead and be active contributor and owner of activities related to Incident Management, Change Management and ongoing operations of the eDMS
Lead internal resource allocations and oversight for vendors delivering eDMS services
Lead a high performing Business Administration team supporting 24/7 operations to ensure continuous and timely availability of CDM content for global business users
Recruits, retains, manages and develops associates through coaching and feedback, talent reviews, and managing performance.
Key member of cross-functional teams on business process, performance or system enhancement initiatives focused on Document Management systems used by Clinical and Regulatory Affairs teams, as required & support CDGM and business teams in preparation for and during audits & inspections.
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:
Education: Bachelor’s degree in life science/healthcare or IT.
Languages: Fluent English (oral and written)
Extensive experience working in Pharmaceuticals, Lifesciences and Clinical Research with specific experience in managing clinical document management, TMF and/or records & information management with prior experience in Electronic Document Management systems, specifically in Clinical and Regulatory highly desired.
Business relevant technical and working experience of Veeva Vault Clinical vault including knowledge of system design
Knowledge of RIM, Documentum D2LS or similar & deep knowledge of industry wide Electronic and Clinical Document Management systems and features
Experience in team management or matrix management of project/clinical teams.
Ability to develop relationships and communicate with IT organisations
Experience of systems implementation or designed and led solutions with business interactions (Senior Business Analyst in Clinical space)
Experience of data migrations between clinical systems is strongly preferred
Deep understanding of drug development process, international drug approval procedures and standards (e.g. ICH-E3, ICH-E6, eCTD) and industry-wide standards in clinical document management (e.g. DIA TMF reference model).
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
What you’ll bring to the role:
Education: Bachelor’s degree in life science/healthcare or IT.
Languages: Fluent English (oral and written)
Extensive experience working in Pharmaceuticals, Lifesciences and Clinical Research with specific experience in managing clinical document management, TMF and/or records & information management with prior experience in Electronic Document Management systems, specifically in Clinical and Regulatory highly desired.
Business relevant technical and working experience of Veeva Vault Clinical vault including knowledge of system design
Knowledge of RIM, Documentum D2LS or similar & deep knowledge of industry wide Electronic and Clinical Document Management systems and features
Experience in team management or matrix management of project/clinical teams.
Ability to develop relationships and communicate with IT organisations
Experience of systems implementation or designed and led solutions with business interactions (Senior Business Analyst in Clinical space)
Experience of data migrations between clinical systems is strongly preferred
Deep understanding of drug development process, international drug approval procedures and standards (e.g. ICH-E3, ICH-E6, eCTD) and industry-wide standards in clinical document management (e.g. DIA TMF reference model).
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
Development
GCO GDD
Ireland
Dublin
Novartis Ireland Limited
United Kingdom
Research & Development
Full Time
Regular
No
