TMF Repositories Support Lead

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

TMF Repositories Support Lead - Sponsor dedicated

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.

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.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.