Trial Master File Oversight Manager

Job Description Summary

Job Title: Trial Master File (TMF) Oversight Manager

#LI-Hybrid

Primary Location: Dublin Ireland

Relocation Support: This role is based in Dublin Ireland. 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 youll collaborate with cross-functional teams to strengthen governance elevate standards and drive continuous improvement in TMF processeshelping 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

• Bachelors 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

Skills Desired

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