Novartis
Trial Master File Oversight Manager
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Salary Range: £49,140.00 - £91,260.00
Band Level 4
Job Description Summary
Job Title: Trial Master File (TMF) Oversight Manager
#LI-Hybrid
Primary Location: London (The Westworks), United Kingdom
Relocation Support: This role is based in London, United Kingdom. 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
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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
- 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
Benefits & Rewards
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
Expected Annual Base Salary Range for role: Add full benchmark as per Workday eg: 49,140 to 91,260 GBP ANN
The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
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Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.
Read our brochure to learn more about our global total rewards offering:
https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.
Commitment to Diversity and Inclusion / EEO
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 Protocols
- Clinical Trials
- Coaching
- Data Analysis
- Data Integrity
- Learning Design
- Lifesciences (Inactive)
- Risk Monitoring
- Trend Analysis
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