Clinical Document Migrations Manager
Posted 2 days 16 hours ago by Novartis Farmacéutica
: Dublin, Ireland This role is based in Dublin, Ireland. 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 (BDL) deals and TMF Document transfers ensuring compliance in collaboration with other Clinical Document Governance Management (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.
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 data 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 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; experience in Veeva Vault related migrations is a strong advantage.
- Deep knowledge of Agile working methodologies.
- Excellent communication, influencing, and stakeholder management skills across global teams.
Expected Annual Base Salary Range for role: €55,370 to €102,830.
In addition to base salary, you may be eligible for a performance based bonus depending on certain performance parameters. Novartis also offers competitive benefits such as insurance plans, retirement plans, wellbeing resources, and global recognition programs. Flexible and hybrid working options are available where possible, with 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.
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.