Experienced Study Start Up Specialist

Role: Senior Study Start‑Up Specialist / Study Start‑Up Specialist II (FSP)

Location: Home‑based, Australia

We are currently seeking a Study Start‑Up Associate to join our diverse and dynamic team. In this role at ICON, you will work within a large‑scale, fast‑paced FSP environment, supporting the Study Start‑Up Team Lead in the planning and execution of country‑ and site‑level start‑up activities.

Your expertise will be critical in delivering high‑quality Study Start‑Up (SSU) activities across assigned countries, ensuring the efficient initiation and progression of clinical trials in compliance with local regulatory and ethics requirements.

As the first (Senior) Study Start‑Up Associate to join this FSP team in Australia, this is a rare opportunity to make a meaningful impact from day one. You will play a key role in shaping local start‑up practices, contributing regional expertise, and supporting the successful expansion of this partnership.

What You Will Be Doing

Your Profile

• Bachelor’s degree (or local equivalent) in a medical, scientific, or related discipline, or equivalent relevant experience.
• Minimum of 3 years’ experience in a Study Start‑Up or Regulatory Start‑Up role within a CRO, pharmaceutical, or biotechnology organisation in Australia.
• Demonstrated experience with Australian study start‑up activities, including:
  • HREC / Ethics submissions and approvals
  • Australian regulatory submissions and local requirements
  • Site start‑up coordination and documentation
• Strong understanding of local start‑up processes and stakeholder engagement within Australia.
• Experience with site contracts and budgets is highly desirable and considered a strong advantage.
• Ability to work effectively in a fast‑paced, matrixed, and collaborative environment.

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