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CDM Migration Business Lead

4 months ago

Dublin, Dublin City, Ireland Healthcare Businesswomen's Association Full time
About the role

Clinical Document Governance Management (CDGM) oversees the strategy and execution of clinical document management (CDM) systems, processes, standards, and operations of CDM services across Novartis globally.

CDGM is leading the transformation of Trial Master File (TMF) at Novartis by introducing new technologies, processes, and ways of working.

The CDM Migration Business Lead is tasked with planning and executing migrations to and from Novartis' clinical electronic document management systems (eDMS), aligning with business needs, and collaborating with technical vendors, internal IT, and business stakeholders.

  • Ensure effective planning and delivery of migrations.
  • Drive implementation of CDGM initiatives and process improvements.

Act as the main point of contact for planning and executing migrations, collaborating with IT and business stakeholders, in alignment with business requirements.

  • Collaborate with stakeholders to identify migration business requirements.
  • Contribute to ensuring efficient system integrations.

Act as a Subject Matter Expert for training materials and tools for eDMS migration activities.

  • Support forecasting resource allocations for migration roadmap management.
  • Execute vendor oversight and identify improvement opportunities to the operating model.

Act as an escalation point for issues, provide support for inspections/audits, and contribute to root cause analysis.

Commitment to Diversity & Inclusion: Novartis aims to create an inclusive work environment and diverse teams reflective of the patients and communities served.

Role Requirements

The role is available in Ireland, India, Switzerland, or the UK.

  • Advanced degree or Bachelor's degree in information or life sciences/healthcare.
  • Minimum 6 years of experience in Pharmaceuticals, Life Sciences, and Clinical Research.
  • Minimum 5 years of full-scale migrations experience.
  • Minimum 2 years of Veeva-related migration planning experience.
  • Prior experience in Electronic Document Management systems, especially in Clinical and Regulatory.
  • Knowledge of eDMS systems like Veeva Clinical vault, RIM, Documentum D2LS or similar.
  • Deep understanding of Agile methodologies and cross-functional team collaboration.
  • Strong influencing and presentation skills.

You'll receive: Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.

Why consider Novartis?
236 million lives were touched by our products in 2022. While proud of this, we continue to strive for improvement to impact more lives. Join us in an inspiring environment where curious, courageous, and collaborative individuals like you can make a difference.

Imagine what you could do at Novartis. Join our Novartis Network.