Study Start-up Manager

ICON Clinical Research, LP

Sydney, Australia
Fully remote
Country-level study start-up
Irb/iec and health authority submissions
Site selection and start-up
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 start-up
  • ICH/GCP and regulatory frameworks
  • Stakeholder engagement and collaboration

Nice-to-have

  • Innovation in start-up processes
  • Patient-focused environment
  • Thrives on ownership
  • Solutions-oriented mindset

Key Requirements

  • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field
  • Proven experience in Study Start-Up / Regulatory Operations in Australia
  • Demonstrated leadership experience within trial start up
  • Strong knowledge of ethics committee requirements
  • Ability to manage complex timelines and submissions

Work Rights

Not specified

Tailored Resume

Cover Letter