Trial master file oversight manager

Job Description Summary

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Job Title: Trial Master File Oversight Manager
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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.
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 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 xpzdshu 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
Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired

Budget Management
Clinical Research
Clinical Trial Protocol
Clinical Trials
Coaching
Data Analysis
Data Integrity
Learning Design
Lifesciences
Risk Monitoring
Trends Analysis

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