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 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.

Job Description

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 equiva

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