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.

　　But in this world of digital and technological transformation, we must also continue to evolve our approaches to clinical document management and unleash the power of information from this expanding universe of data.

　　Your responsibilities include but not are limited to:

　　• Delivery of high quality and timely TMF Quality Review activities for a portfolio of internal

　　studies.

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

　　• Responsible for timely assessment of quality and completeness of TMFs for an assigned portfolio of studies. Identifies and communicate TMF risks/trends/patterns and works with key collaborators to define and implement pragmatic remediations.

　　• Executes vendor oversight plan, monitors service metrics and finds opportunities for improvement to the operating model. Acts as point of escalation for issues.

　　• Serves as Subject Matter Expert on TMF training materials, formal and informal processes and tracking tools for TMF oversight activities in collaboration with CDM Process team and other key collaborators

　　• Provides Audit/Inspection readiness support by driving TMF quality reviews in preparation for audits/inspections, contributes to root cause analysis identification and creation/delivery of CAPAs.

　　• Identify and implement improvements to document management processes to improve quality of TMFs. May act as business lead for innovation projects to enhance TMF quality assessment.

　　• Supports the forecasting and tracking of TMF Quality Review resource needs including proactive identification of resources to support TMF Quality Review activities for high-risk and priority projects

　　• Supports definition and refinement of TMF management strategy for assigned portfolio of studies. Ensures clear expectations for TMF set up and maintenance, including contractual agreement with third parties, for outsourced studies.

　　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

　　The role can be based in either UK (homebased) or Ireland (hybrid in Dublin) Please note relocation will not be provided.

　　What You'll bring to the role:

　　• 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 driving cross functional projects.

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

　　• High 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 customers.

　　#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

　　Division

　　Development

　　Business Unit

　　GCO GDD

　　Location

　　United Kingdom

　　Site

　　National

　　Company / Legal Entity

　　Novartis Pharmaceuticals UK Lt

　　Alternative Location 1

　　Ireland

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No