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 TMF Oversight Integration Manager ensure successful planning and transition of TMF documentation to and from Novartis in support of BD&L projects and Out licensing activities. Drives implementation of CDGM initiatives, projects and process improvement activities to enhance clinical document management systems, processes and standards at Novartis.

　　Major Accountabilities:

　　• Act as CDGM point of contact for assigned portfolio of In-Licensing / Out-Licensing / Acquisition / Divestment Projects, collaborating with key stakeholders with CDGM teams, Development Informatics, Legal, Development Quality Assurance and Global Project Teams.

　　• Lead and/or Contribute to the development of TMF Transition Plans and ensure the successful transitions of TMF (paper and electronic) documentation outside of Novartis in support of out-licensing and divestment projects, and into Novartis in support of in-licensing and acquisition projects.

　　• Develop and maintain paper and electronic document processes & standards relating to BD&L projects and Out licensing activities, in compliance with internal and external requirements & regulations.

　　• Identify and communicate risks/trends/patterns relating to TMF, BD&L projects, Out licensing activities and work with key stakeholders to define and implement pragmatic remediations.

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

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

　　• Provides support for inspections/audits, contributes to root cause analysis identification and creation/delivery of CAPAs.

　　• ISupports the TMF Integration Lead with respect to forecasting and planning of B&&L projects.

　　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 is a remote position based in the United Kingdom

　　What you'll bring to the role:

　　• Bachelor's degree or equivalent and relevant industry experience

　　• English fluency (written, oral) required

　　• 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 executing cross functional projects.

　　• 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.

　　#GCO

　　#CDGM

　　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