Study Startup Specialist II — Australia (Hybrid)

Psi CRO; Sydney; Hybrid; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work arrangement

Onsite parking

Learning and development

Mental wellness programs

Novated leasing

Meaningful industry work

Job summary

PSI CRO in Sydney is seeking a Study Startup Specialist II for an 18-month contract to lead study activation in Australia. The role supports clinical research teams, manages startup timelines, budgets, and regulatory documents, and ensures timely site activation.

Based in Sydney with a hybrid work arrangement, you will collaborate with cross-functional teams, maintain startup tracking systems, and contribute to high-quality documentation and submissions.

Qualifications

• At least 2 years of industry experience in clinical research as a Study Startup Specialist, or similar role in Australia.
• Bachelor’s degree or above, preferably in pharmaceutical/healthcare-related majors.
• Excellent communication skills, both written and verbal.
• Full working proficiency in English.
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook).

Responsibilities

• Maintains study-specific and corporate startup tracking systems
• Facilitates site budgets and contract negotiations
• Supports site regulatory document collection
• Under supervision, may prepare initial and amendment submission dossiers to competent authorities, ethics committees, and/or site submission dossiers
• Communicates with the project team and investigational sites throughout the entire duration of the study
• Develops site specific startup timelines and enrollment projections and is responsible for meeting the site activation milestones
• May review study specific translations
• Supervises Trial Master File (TMF) maintenance throughout the study startup phase

Skills

Study Startup

Communication skills

English proficiency

MS Office

Education

Bachelor’s degree or above

Tools

MS Office

Job description

PSI CRO in Sydney is seeking a Study Startup Specialist II for an 18-month contract to lead study activation in Australia. The role supports clinical research teams, manages startup timelines, budgets, and regulatory documents, and ensures timely site activation.

Based in Sydney with a hybrid work arrangement, you will collaborate with cross-functional teams, maintain startup tracking systems, and contribute to high-quality documentation and submissions.