Job Description

(Senior) Study Start‑Up Associate – Unique FSP Opportunity | Home‑Based in Australia

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

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

• Efficiently Drive Study Initiation: Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities.
• Empower Success through Specialized SSU Expertise: Provide expertise to Study Start Up team leads and project teams, providing valuable insights to drive success.
• Ensuring Regulatory Compliance: Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines.
• Safeguarding Patient Welfare: Contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, guaranteeing the highest standards of patient safety and informed consent.

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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What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements

• A range of health insurance offerings to suit you and your family’s needs.

• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.

• Life assurance

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply