Summary

This role is based in Barcelona, Spain. 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 will 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 the CGDM team and reports directly to the Clinical Document Management: Migration Team Lead.

Key Responsibilities

- 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 and audits, contribute to root cause analysis and creation/delivery of CAPAs.

Essential Requirements

- Degree in information or life sciences/healthcare and extensive experience in pharmaceuticals, life sciences, and clinical research.
- Proven track record in leading clinical document management, TMF and/or records & information management, with deep knowledge of the Trial Master File reference model and experience in electronic document management systems, specifically in clinical and regulatory systems (e.g., Veeva Clinical Vault, RIM, Documentum D2LS).
- Solid portfolio of full‑scale migrations of clinical documents, particularly eTMF; experience in Veeva Vault‑related migrations is a strong advantage.
- Deep knowledge of Agile working methodologies.




- Excellent communication, influencing, and stakeholder management skills across integral teams.

Benefits & Rewards

Expected annual base salary range for the role: €46,300 to €86,100. The base salary offered is determined based on gender‑neutral objectives such as relevant skills, competencies and experience in accordance with Novartis pay‑setting policy and will be reviewed periodically upon joining. In addition to your base salary, you may be eligible for a performance‑based bonus depending on certain performance parameters. You will also have access to competitive benefits in kind, including insurance plans, retirement plans, wellbeing resources, global recognition programs, flexible and hybrid working options where possible, and a minimum of 14 weeks paid parental leave.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to creating a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

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.

About 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 to bring breakthroughs that change patients’ lives. Ready to create a brighter future together?

References

For more information on our global total rewards offering, please refer to the Novartis Life Handbook PDF:

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📌 Clinical Document Migrations Manager (Barcelona)
🏢 Novartis
📍 Barcelona