Trial Master File Oversight Manager
Summary
Job Title: Trial Master File Oversight Manager
\#LI\-Hybrid
Location: Barcelona Gran Via, Spain
Relocation Support: This role is based in Barcelona Gran Via, Spain. 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
- 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
- People Management experience
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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
Spain
Site
Barcelona Gran Vía
Company / Legal Entity
ES06 (FCRS \= ES006\) Novartis Farmacéutica, S.A.
Functional Area
Research \& Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
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