Study Startup Specialist I
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About the role
PSI seeks a Study Startup Specialist I in Sydney to support clinical study start-up in Australia. Responsibilities include tracking start-up activities, facilitating site budgets and contracts, collecting regulatory documents, supporting ethics and site submissions, coordinating with project teams and sites, meeting activation milestones, reviewing translations, and maintaining the TMF. The role requires at least one year of clinical development experience including start-up experience, EC submission experience, a bachelor’s degree or above, English proficiency, and MS Office skills.
Key requirements
- • Bachelor’s degree or above, preferred in pharmaceutical/healthcare related majors
- • At least 1 year of relevant experience
- • Required skills: clinical development experience, clinical trial start-up process experience, EC submissions, written and verbal communication, English proficiency, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook
- • Required language: English
Opportunity details
- • Workplace: Hybrid
- • Posted: Nov 2, 2026
- • Original advert language: English
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See original vacancy ↗Employer’s role description
Job title: Study Startup Specialist I
Location: Sydney, NSW, Australia
Employment type: Full-time
Workplace type: Hybrid
Company Description
PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.