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 Process User Support Team Lead is accountable for leading a Clinical Document Management sub team, ensuring effective planning, delivery and oversight for a defined portfolio of Clinical Document Governance Management (CDGM) services

　　Identifies, plans and drives implementation of CDGM initiatives, projects and process improvement activities to enhance clinical document management systems, processes and standards at Novartis.

　　The role can be based in either in Ireland, United Kingdom or India.

　　Major Accountabilities:

　　• Lead a team delivering user support related to clinical document management processes, adoption of Trial Master File (TMF) and good documentation practices across the business.

　　• Identifies, plans and drives implementation of CDGM initiatives, projects and process improvement activities to enhance clinical document management systems, processes and standards at Novartis.

　　• Act as CDGM contact for key stakeholders, collaborating with them to improve clinical documentation process, systems and capabilities across the organization.

　　• Delivers excellence in service delivery, including optimization and simplification in compliance with Novartis policies & regulatory requirements, responding in an agile way to new or evolving business priorities.

　　• Provide robust oversight of 3rd party vendor activities including monitoring sustainable performance against SLAs.

　　• Lead or contribute to cross functional initiatives or projects, including defining and gaining approval for projects or initiatives, and ensuring deliverables are achieved in line with agreed timeframes and budget.

　　• Embeds a risk-based mindset across the team and in service delivery, ensuring identification, evaluation and management of risks, including mitigation activities.

　　• Set priorities, manage schedules and develop robust resourcing model to support timely delivery of TMF services.

　　• Support CDGM and business teams in preparation for and during audits, inspections and migration activities. Own CAPAs arising from inspections/audits ensuring they are closed out on time.

　　• Leads team, recruits, retains, manages and develops associates through coaching and feedback, talent reviews and other available Novartis resources and tools, and fosters a safe environment for team dialogue and growth.

　　v=ggbnzRY9z8w

　　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

　　What you'll bring to the role:

　　• Advanced degree or combination of Bachelor's degree in life-sciences/healthcare/pharmacy and relevant industry experience

　　• English fluency (written, oral) required

　　• Minimum of 8 years of 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.

　　• Minimum of 3 years' 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).

　　• Demonstrated success in planning and executing cross functional projects.

　　• Strong influencing and presentation skills. Ability to communicate effectively at all levels.

　　• Good organizational 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.

　　#GCO

　　#CDGM

　　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

　　Novartis Ireland Ltd. has been certified as a Top Employer 2022 by the Top Employers Institute for its exceptional employee offerings!

　　Division

　　Development

　　Business Unit

　　GCO GDD

　　Location

　　Ireland

　　Site

　　Dublin

　　Company / Legal Entity

　　Novartis Ireland Limited

　　Alternative Location 1

　　India

　　Alternative Location 2

　　United Kingdom

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No