Study Start-up Manager

ICON

Sydney, Australia
Fully remote
Country-level study start-up
Irb/iec and health authority submissions
Site selection and milestone delivery
As a Study Start-Up Lead, you will play a key role in accelerating the delivery of transformative therapies to patients, driving country-level study start-up activities from planning to Green Light

Job Summary

  • As a Study Start-Up Lead, you will play a key role in accelerating the delivery of transformative therapies to patients, driving country-level study start-up activities from planning to Green Light.
  • You will work with high-performing global and local teams, champion innovation in start-up processes, and gain exposure to cutting-edge clinical trials in a collaborative, patient-focused environment.
  • ICON offers a range of additional benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family.

Matching Summary

As a Study Start-Up Lead, you will play a key role in accelerating the delivery of transformative therapies to patients, driving country-level study start-up activities from planning to Green Light.

Skills & Requirements

Must-have

  • Country-level study start-up
  • IRB/IEC and Health Authority submissions
  • Site selection and milestone delivery
  • Inspection-ready TMF documentation
  • ICH/GCP and regulatory frameworks

Nice-to-have

  • Champion innovation in start-up processes
  • Patient-focused environment
  • Solutions-oriented mindset
  • Thrive in a fast-paced global environment

Key Requirements

  • Bachelor’s degree in Life Sciences or related field
  • Proven experience in Study Start-Up / Regulatory Operations in Australia
  • Demonstrated leadership experience in trial start up
  • Strong knowledge of ethics committee requirements
  • Excellent stakeholder engagement skills

Work Rights

Not specified

Tailored Resume

Cover Letter