Title: TMF SWAT Manager
Company: Novartis
Location: United Kingdom (Hybrid – London, Dublin, or Hyderabad offices)
Job ID: REQ-10045337
Posted Date: April 29, 2025
Work Type: Hybrid (12 days/month onsite)
Function: Clinical Development Document & Governance Management
Industry: Pharmaceuticals / Clinical Research
Job Summary:
This role offers an opportunity to lead and support strategic TMF (Trial Master File) integration and transition activities for licensing and acquisition projects. As TMF SWAT Manager, you will work cross-functionally with stakeholders across legal, quality, informatics, and global project teams to ensure documentation compliance and operational excellence.
Key Responsibilities:
Serve as the primary CDGM contact for in-licensing, out-licensing, acquisition, and divestment TMF projects
Develop TMF transition plans for both paper and electronic documentation
Ensure successful documentation transitions into or out of Novartis
Create and maintain processes and standards for BD&L (Business Development and Licensing) projects
Identify risks and patterns in TMF transitions and implement mitigations with stakeholders
Oversee vendors, service metrics, and act as escalation point for issues
Serve as subject matter expert on TMF training, processes, and oversight tools
Support audit and inspection preparation and CAPA execution
Drive innovation and continuous improvement in TMF integration activities
Support TMF Integration Lead in project planning and forecasting
Required Experience and Skills:
Minimum 5 years of experience in clinical research or development in the pharmaceutical or CRO industry
Strong background in clinical documentation or records and information management
Demonstrated success in leading cross-functional projects
Strong influencing, communication, and presentation skills across global teams
High organizational awareness; experience in multinational, cross-cultural environments
Problem-solving, negotiation, and conflict resolution abilities
Proficient in English
Why Join Novartis:
At Novartis, you’ll join a global community committed to reimagining medicine. You’ll work in a collaborative environment where your contributions help transform patients’ lives.
Learn more:
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