At a Glance
- Tasks: Lead and execute clinical document migrations, driving digital transformation in healthcare.
- Company: Join Novartis, a leader in pharmaceuticals with a commitment to innovation.
- Benefits: Competitive salary, performance bonuses, flexible working, and comprehensive benefits.
- Other info: Diverse and inclusive workplace with excellent career growth opportunities.
- Why this job: Make a real impact on healthcare by managing critical document migrations.
- Qualifications: Degree in life sciences or healthcare with experience in clinical document management.
The predicted salary is between 49140 - 91260 £ per year.
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 (e TMF) 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.
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 (e DMS) migration activities.
- Manage activities related to migration‑related Incident Management, Change Management, and ongoing operations of the e DMS.
- Support the forecasting of internal resource allocations and vendor‑provided activities as part of e DMS 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.
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 a deep knowledge of the 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 e TMF; experience 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
Expected Annual Base Salary Range for role: 49,140 to 91,260 GBP.
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 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.
We provide 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 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.
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.
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Clinical Document Migrations Manager employer: Novartis Farmacéutica
At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the healthcare sector. Our commitment to employee growth is evident through continuous training and development opportunities, ensuring that our team members can thrive while making a meaningful impact on patient access to life-changing medicines in Southwest England and South London.
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