Trial Master File Oversight Manager

Summary Job Title: Trial Master File (TMF) Oversight Manager 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 RoleKey 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)