Study Startup Specialist II – 18‑Month Contract

About the role

Join PSI CRO as a Study Startup Specialist II on an 18‑month contract, supporting clinical research teams in Australia. You will help ensure that PSI projects start smoothly, on time, and meet all regulatory and site activation milestones.

Key responsibilities

• Maintain study‑specific and corporate startup tracking systems.
• Facilitate site budgets and contract negotiations.
• Support site regulatory document collection and preparation of submission dossiers.
• Communicate with project teams and investigational sites throughout the study.
• Develop site‑specific startup timelines and enrollment projections.
• Review study‑specific translations and supervise Trial Master File maintenance during startup.

Required profile

• Minimum 2 years of industry experience in clinical research or study startup.
• Bachelor’s degree or higher, preferably in pharmaceutical/healthcare related fields.
• Excellent written and verbal communication skills in English.
• Full working proficiency in English.
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook).

Required skills

• MS Office – Word
• MS Office – Excel
• MS Office – PowerPoint
• MS Office – Outlook

What we offer

• Hybrid work arrangement: two days remote, three days onsite.
• Onsite parking at Macquarie Park office.
• Opportunities for learning and professional development.
• Access to mental wellness programs.
• Novated leasing options.
• Work within a meaningful, global medical research environment.