Trial Master File Oversight Manager
Posted 6 days 23 hours ago by Healthcare Businesswomens Association
Job Title: Trial Master File (TMF) Oversight Manager
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, 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
- 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
- People Management experience
- Budget Management
- Clinical Research
- Clinical Trial Protocol
- Clinical Trials
- Coaching
- Data Analysis
- Data Integrity
- Learning Design
- Lifesciences
- Risk Monitoring
- Trends Analysis