Descripción del trabajo - Trial Master File Oversight Manager
Band Level 4
Job Description 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.
Job Description
Key Responsibilities
- Provide oversight for the assessment of quality and completeness of Trial Master Files across a general 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 equ

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