Trial Master File Oversight Manager

Summary

Job Title: Trial Master File (TMF) Oversight Manager

\#LI\-Hybrid

Primary Location: Dublin, Ireland

Relocation Support: This role is based in Dublin, Ireland. Novartis is unable to offer relocation support: please only apply if accessible.

When you bring structure to complexity, you unlock better outcomes for patients. As a Trial Master File (TMF) Oversight Manager, you will play a critical role in ensuring the quality, integrity, and readiness of clinical trial documentation across a global portfolio. Working at the heart of clinical operations, you’ll collaborate with cross\-functional teams to strengthen governance, elevate standards, and drive continuous improvement in TMF processes—helping Novartis deliver high\-quality research and transform patient care worldwide.

About the Role

Key Responsibilities

• Provide oversight for the assessment of quality and completeness of Trial Master Files across a global portfolio


• Identify and communicate trends, risks, and gaps in documentation and implement effective remediation plans


• Lead vendor Trial Master File oversight activities, monitor performance metrics, and optimize operating models


• Act as escalation point for Trial Master File quality issues and drive timely resolution


• Serve as subject matter expert on Trial Master File processes, tools, and training materials


• Support audit and inspection readiness through proactive quality reviews and preparation activities


• Contribute to root cause analysis and develop corrective and preventive action plans


• Drive continuous improvement in document management processes to enhance Trial Master File quality


• Lead or support innovation initiatives to advance Trial Master File systems and assessment approaches


• Support resource planning, forecasting, and prioritization of Trial Master File high\-risk and critical studies

Essential Requirements

• Bachelor’s degree or equivalent with relevant experience in the pharmaceutical or clinical research industry


• Minimum of five years’ experience in clinical research and development, including clinical documentation or records management


• Proven ability to plan and execute cross\-functional projects in a complex, global environment


• Strong influencing and presentation skills with the ability to communicate clearly at all organizational levels


• Experience working in multidisciplinary teams across different cultures and geographies


• Strong organizational awareness with the ability to manage multiple priorities effectively


• Demonstrated problem solving, negotiation, and conflict resolution skills


• Ability to build and maintain trusted relationships with internal and external stakeholders

Desirable Requirements

• People Management experience

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people\-and\-culture

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)

Division
Development
Business Unit
Development
Location
Ireland
Site
Dublin (NOCC)
Company / Legal Entity
IE02 (FCRS \= IE002\) Novartis Ireland Ltd
Functional Area
Research \& Development
Job Type
Full time
Employment Type
Regular
Shift Work
No

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