Job ID275647BRPosition TitleTMF Repositories Support LeadApply to Job
Job Description
20 +! This is currently the approximate number of TMF systems or repositories at Novartis. As TMF Repositories Support Lead, you will act as business lead for integration and interfaces of TMF repositories and support improvements and innovation on business and technical aspects of document management and archiving, including implementation of innovative methods.
Your main responsibilities will include, but not limited to:
• Ensure as a Business lead that assigned systems/tools (e.g. VirtualTOC, eTMF4 etc) can support Clinical Trial Teams and inspector/auditor activities.
• Provide support before, during and after audits and inspections on questions related to TMF systems, tools and processes.
• Support the strategy for integration and/or interfaces of identified TMF repositories with the new Document Management System and assess future systems functionalities to ensure compliance with regulatory requirements. 1) Maintain and implement the plan for integration and or interfaces of identified TMF repositories into the new Document management System. 2) Ensure compliant storage of TMF documents/data in Novartis by developing and supervising trainings courses, migration procedures and processes. 3) Contribute to the implementation of global plan for archiving the electronic TMF documents authored/imported in the different Novartis Systems.
• Support future releases of new document management system by providing direct input to the user requirements, change requests, file plan, migration, testing and deployment
• Support enhancement of TMF documents/data access throughout the company and for inspections,
• Act as a Core member of the TMF Governance Team for any TMF related questions and supporting procedures, guidelines and tools update/creation.
Minimum requirements
What you’ll bring to the role:
• College degree or equivalent education in life science/healthcare or related scientific discipline (natural, pharmaceutical, medical, archival or information technology).
• Fluent English (oral and written)
• At least 5 years of relevant experiences in managing, archiving, retrieving or compiling clinical documents / At least 6 years of relevant clinical research/pharmaceutical industry experiences
• Lead Expert in electronic Trial Master File systems and Archiving
• Good organizational and IT skills and significant project work or project management experience
Additional requirements:
• Experience with stakeholder management in a matrix organization.
WHY CONSIDER NOVARTIS?
750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.DivisionGlobal Drug DevelopmentBusiness UnitGDO GDDLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaQualityJob TypeFull TimeEmployment TypeRegular
