Trial Master File Oversight Manager

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