Study Start-up Manager

ICON plc

Sydney, Australia
Not specified; not specified; competitive salary w...
Fully remote
Study start-up experience in australia
Irb/iec submission management
Ich/gcp regulatory knowledge
This role involves leading country-level study start-up activities from planning to Green Light across assigned projects within a global biopharmaceutical organization

Job Summary

  • This role involves leading country-level study start-up activities from planning to Green Light across assigned projects within a global biopharmaceutical organization.
  • The successful candidate will prepare and finalize IRB/IEC submissions while ensuring timely site selection and inspection-ready TMF documentation.
  • ICON offers a competitive salary, diverse benefits including health insurance and retirement planning, and a culture dedicated to inclusion and belonging.

Matching Summary

This role involves leading country-level study start-up activities from planning to Green Light across assigned projects within a global biopharmaceutical organization.

Salary

Not specified; Not specified; Competitive salary with range of additional benefits

Skills & Requirements

Must-have

  • Study Start-Up experience in Australia
  • IRB/IEC submission management
  • ICH/GCP regulatory knowledge
  • Cross-functional team leadership
  • Country-level start-up delivery

Nice-to-have

  • Passion for operational excellence
  • Innovation in start-up processes
  • Patient-focused environment
  • Global collaboration skills

Key Requirements

  • Bachelor's degree in Life Sciences or related field
  • Proven experience in Study Start-Up within CRO or pharma in Australia
  • Demonstrated leadership managing teams and cross-functional initiatives

Work Rights

Not specified

Tailored Resume

Cover Letter