Clinical Document Migrations Manager

Salary Range:

€46,300.00 - €86,100.00

 

Band

Level 4

 

Job Description Summary

#LI-Hybrid

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'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

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/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 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: 46,300 to 86,100 EURO

  

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 Model