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.

　　The CDM Technology Team Lead drives CDGM strategic initiatives related to implementation, operations and business administrative support for enterprise document management systems to manage Clinical Documents originating from Clinical Trials.

　　Your responsibilities:

　　Your responsibilities include, but are not limited to:

　　• Act as key CDGM/TMF contact for Regulatory Affairs, Quality with the Porfolio Execution Organisation (PEO) to ensure CDGM service are aligned with regulatory and other stakeholder requirements in relation to completeness of TMF and management of Clinical Trial Documents.

　　• Lead and drive system strategy roadmap and efficient processes & integrations based on solid understanding of the Novartis enterprise systems landscape and as per compliance and business priorities.

　　• Partners effectively with cross-functional stakeholders (e.g., Regulatory Affairs, Quality) to ensure CDM systems 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 electronic Document Management System(s)

　　• Lead internal resource allocations and oversight for vendors delivering CDM Systems 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

　　• Leads the CDM Technology team - 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

　　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 eDMS systems like Veeva Clinical vault, RIM, Documentum D2LS or similar &n deep knowledge of industry wide Electronic and Clinical Document Management systems and features

　　• Functional knowledge of business process and workflows used for Clinical, TMF, Regulatory functions

　　• Experience in direct people management or matrix management of project/clinical teams.

　　• 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

　　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

　　Division

　　Development

　　Business Unit

　　GCO GDD

　　Location

　　Ireland

　　Site

　　Dublin

　　Company / Legal Entity

　　Novartis Ireland Limited

　　Alternative Location 1

　　United Kingdom

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No