Salary Range:
£49,140.00 - £91,260.00Job Description Summary
#LI-HybridLocation: London, United Kingdom
This role is based in London, United Kingdom. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.
The Clinical Document Governance & Management (CDGM) is responsible for the strategy and implementation of clinical document management (CDM). As Clinical Document Migrations Manager, you'll take on strategy, planning, and delivery of migrations to, from, and within Novartis enterprise-wide clinical electronic document management systems. This role offers a unique opportunity to influence enterprise-wide digital transformation, working at the intersection of business and technology to drive migration initiatives with an objective of overall electronic Trial Master File (eTMF) system consolidation, TMF integration for Business Development & Licensing (BD&L) deals and TMF Document transfers ensuring compliance in collaboration with other CDGM groups, business and Information Technology (IT) departments. If you are passionate about driving change and delivering solutions that ultimately support bringing life-changing therapies to patients, this is your opportunity to make a meaningful impact.
The position is part of CGDM team and reports directly to Clinical Document Management: Migration Team Lead.
Job Description
- Lead end-to-end planning and execution of clinical document migrations.
- Drive CDGM initiatives to improve migration strategy, governance, and operational execution
- Partner with internal and external stakeholders to plan and execute migrations, ensuring alignment with Novartis business, compliance, and operational requirements.
- Collaborate with stakeholders to identify and agree on migration business requirements, understand source and target system capabilities and develop a future migration roadmap.
- Serve as a Subject Matter Expert for training materials and tracking tools for electronic document management system (eDMS) migration activities.
- Manage activities related to migration-related Incident Management, Change Management, and ongoing operations of the eDMS.
- Support the forecasting of internal resource allocations and vendor-provided activities as part of eDMS migration roadmap management.
- Execute the vendor oversight plan, monitor service metrics, and identify opportunities for improvement.
- Provide support for inspections/audits, contribute to root cause analysis and creation/delivery of CAPAs.
- Degree in information or life sciences/healthcare and extensive experience in Pharmaceuticals, Life sciences, and Clinical Research
- Proven track record in leading of clinical document management, TMF and/or records & information management, with a deep knowledge of Trial Master File (TMF) reference model and experience in Electronic Document Management systems, specifically in Clinical and Regulatory (e.g. Veeva Clinical vault, RIM, Documentum D2LS)
- Solid portfolio of full-scale migrations of clinical documents, particularly eTMF, experiences in Veeva Vault related migrations will be a strong advantage
- Deep knowledge of Agile working methodologies.
- Excellent communication, influencing, and stakeholder management skills across global teams
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: 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.
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 paragraph
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 Trials, Process Improvements, Project Planning, Vendor Management, Waterfall ModelSkills Required
- Degree in information or life sciences/healthcare
- Extensive experience in Pharmaceuticals, Life Sciences, and Clinical Research
- Proven track record leading clinical document management, TMF and/or records & information management
- Deep knowledge of the TMF reference model and experience with electronic document management systems in Clinical and Regulatory contexts
- Experience with Veeva Clinical Vault, Veeva RIM, or Documentum D2LS (electronic document management systems)
- Portfolio of full-scale migrations of clinical documents, particularly eTMF (Veeva Vault migration experience strongly advantageous)
- Deep knowledge of Agile working methodologies
- Excellent communication, influencing, and stakeholder management skills across global teams
- Budget Management
- Clinical Trials knowledge
- Process Improvements
- Project Planning
- Vendor Management
- Waterfall Model experience
Novartis Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novartis and has not been reviewed or approved by Novartis.
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Healthcare Strength — Pay and benefits are described as a strong overall package, supported by medical, dental, and vision insurance alongside FSAs/HSAs and disability and life coverage. Mental-health support is reinforced through an employee assistance program with psychological support and a network of mental health first aiders.
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Retirement Support — Retirement support is positioned as a standout element, with an automatic company contribution plus dollar-for-dollar matching in the 401(k). Additional retirement funding is described through an age-based defined contribution program and access to an employee share purchase plan discount.
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Parental & Family Support — Family-related benefits are framed as robust, including a global minimum of paid parental leave for new parents following birth or adoption. Added supports include domestic partner coverage, dependent-care resources, and benefits such as adoption assistance and child/elder care options.
Novartis Insights
What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
