Summary:
Job Title: Trial Master File Oversight Manager
- #LI-Hybrid
- Location: Barcelona Gran Via, Spain
- 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 integral 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
- 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 influe

📌 Trial Master File Oversight Manager (Barcelona)
🏢 Novartis
📍 Barcelona