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Tmf Swat Manager

5+ years
Not Disclosed
10 April 30, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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: