Novartis
Trial Master File Oversight Manager
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Trial Master File (TMF) Oversight Manager
#LI-Hybrid Salary Range: £49,140.00 – £91,260.00 | Band Level 4 Primary Location: London (The Westworks), United Kingdom Relocation Support: Novartis is unable to offer relocation support—please only apply if accessible.
About the Role
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, implementing effective remediation plans
- Lead vendor TMF oversight activities, monitor performance metrics, and optimise operating models
- Act as the escalation point for TMF quality issues, driving timely resolution
- Serve as a subject matter expert on TMF processes, tools, and training materials
- Support audit and inspection readiness through proactive quality reviews and preparation
- Contribute to root cause analysis and develop corrective and preventive action (CAPA) plans
- Drive continuous improvement in document management processes to enhance TMF quality
- Lead or support innovation initiatives to advance TMF systems and assessment approaches
- Support resource planning, forecasting, and prioritisation of high-risk and critical studies
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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
- Influence and present clearly at all organisational levels
- Work in multidisciplinary teams across different cultures and geographies
- 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: People management experience)
Skills Desired
Budget Management | Clinical Research | Clinical Trial Protocols | Clinical Trials | Coaching | Data Analysis | Data Integrity | Learning Design | Risk Monitoring | Trend Analysis
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Benefits & Rewards
At Novartis, we’re committed to reimagining medicine—and rewarding those who make it happen.
Compensation:
- Expected Annual Base Salary Range: £49,140 – £91,260 GBP (determined by skills, competencies, and experience)
- Performance-based bonus eligibility
Additional Benefits:
- Competitive insurance and retirement plans
- Wellbeing resources and global recognition programs
- Flexible/hybrid working (where possible)
- 14+ weeks paid parental leave
- Commitment to diversity, equity, and inclusion (DE&I)
Benefits may vary by country and are subject to local legal requirements, including collective bargaining agreements.
Learn more about Novartis’s total rewards offering →
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Novartis does not make job offers without interview—and never asks for money or personal information. If a posting seems fraudulent, do not respond. For suspected scams, we recommend reporting via [TalentNet] or the local recruiting system.
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