Study Startup Specialist I

About the role

Join PSI, a leading Contract Research Organization, to help launch clinical trials in Australia. You will work closely with project teams and investigational sites to move studies from planning to execution.

Key responsibilities

• Maintain study-specific and corporate startup tracking systems.
• Facilitate site budgets, contract negotiations and regulatory document collection.
• Develop site‑specific startup timelines and enrollment projections, ensuring activation milestones are met.
• Maintain the Trial Master File (TMF) for assigned tasks throughout the study lifecycle.

Required profile

• Minimum 1 year of experience in clinical development with startup process exposure.
• Experience with ethics committee (EC) submissions.
• Bachelor’s degree or higher, preferably in pharmaceutical or healthcare related fields.
• Excellent written and verbal communication skills in English.

Required skills

• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook).

What we offer

• Hybrid work arrangement: two remote days and three on‑site days per week.
• On‑site parking at the Macquarie Park office.
• Opportunities for learning, professional development and mental wellness programs.
• Novated leasing options and a meaningful role in a global organization.