Clinical Document Migrations Manager
About the Role
- 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:
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.
Role Requirements
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
