Global Clinical Operations- Study Start-up Manager

Novartis UK

UK
5 years clinical operations experience
Gcp/ich regulatory compliance knowledge
Irb/iec submission package preparation
The role is accountable for study planning, start-up activities, and activation deliverables ensuring compliance with Novartis processes and global regulations

Job Summary

  • The role is accountable for study planning, start-up activities, and activation deliverables ensuring compliance with Novartis processes and global regulations.
  • Candidates must lead all start-up activities in collaboration with feasibility managers, site partnership managers, and the global study team to meet country commitments.
  • The position requires overseeing local vendor selection, managing deficiency letter responses, and ensuring sites are prepared for Green Light initiation.

Matching Summary

The role is accountable for study planning, start-up activities, and activation deliverables ensuring compliance with Novartis processes and global regulations.

Skills & Requirements

Must-have

  • 5 years clinical operations experience
  • GCP/ICH regulatory compliance knowledge
  • IRB/IEC submission package preparation
  • Health Authority liaison capabilities
  • TMF inspection readiness management

Nice-to-have

  • Matrix environment leadership skills
  • Vendor selection and performance oversight
  • Process improvement innovation
  • Conflict resolution and negotiation
  • Budget management capabilities

Key Requirements

  • Degree in scientific or health discipline
  • Minimum 5 years clinical trial experience
  • Fluent in English and local language

Work Rights

Not specified

Tailored Resume

Cover Letter