Trial Master File Oversight Manager

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 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 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