Associate Director, Veeva Study Training System Owner, Global Clinical Solutions

AstraZeneca

Warsaw, Poland
3d onsite
Veeva study training system management
Clinical systems lifecycle management
Regulated environment computer system validation
Global Clinical Solutions drives the delivery of technology and associated processes for the R&D organisation, providing industry leading technology and services

Job Summary

  • Global Clinical Solutions drives the delivery of technology and associated processes for the R&D organisation, providing industry leading technology and services.
  • The System Owner is accountable for the leadership, lifecycle management, and continuous improvement of clinical systems, working closely with internal and external stakeholders.
  • The role involves ensuring compliance with ICH/GxP requirements, managing system risks, prioritizing business requests, and leading improvement projects.

Matching Summary

Global Clinical Solutions drives the delivery of technology and associated processes for the R&D organisation, providing industry leading technology and services.

Skills & Requirements

Must-have

  • Veeva Study Training system management
  • Clinical systems lifecycle management
  • Regulated environment computer system validation
  • Stakeholder engagement and communication
  • Project management skills
  • Lean Six Sigma continuous improvement

Nice-to-have

  • Experience with external vendor collaboration
  • AGILE certification (e.g. SAFe)
  • Quality Systems and Quality Management
  • Incident, Problem, Change and Release Management
  • Business Process development and management
  • Strong interpersonal and negotiation skills

Key Requirements

  • Bachelor of Science degree or equivalent experience
  • Extensive drug development experience in pharmaceutical or clinical background
  • Experience in validation of computerized systems in regulated environments
  • Demonstrated project management skills
  • Experience working with external vendors
  • Knowledge of regulatory requirements (GxP, SOX)
  • Recognised AGILE certification (desirable)
  • Project Management certification (desirable)

Work Rights

Not specified

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