Hybrid Clinical Study Start-Up Specialist

Psi CRO; Sydney; Hybrid; AUD 70,000 - 110,000; Full time

Benefits offered by this job

Hybrid work arrangement

On-site parking

Professional development opportunities

Mental wellness programs

Novated leasing options

Global organization

Job summary

PSI is seeking a motivated Study Startup Specialist I to join our Sydney, NSW team and help launch clinical trials from site contracts through to activation. You will collaborate with project teams and investigational sites, driving timelines, regulatory documentation, and site readiness to move studies efficiently from planning to execution.

Minimum 1 year in clinical development with start-up experience is required; strong English communication skills and proficiency in MS Office are

Qualifications

• Minimum of 1 year of experience in clinical development including start-up process experience.
• Experience with EC submissions.
• Bachelor’s degree or above, preferred 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

• Maintain study-specific and corporate startup tracking systems
• Facilitate site budgets and contract negotiations
• Support site regulatory document collection
• Under supervision, may prepare initial/amendment submission dossiers to ethics committees, and/or site submission dossiers (as applicable)
• Communicates with the project team and investigational sites throughout the study lifecycle
• Develop site specific startup timelines and enrollment projections and is responsible for meeting the site activation milestones
• May review study specific translations
• Responsible for maintaining the Trial Master File (TMF) for assigned tasks throughout the study lifecycle

Skills

Clinical start-up

EC submissions

Communication skills

English proficiency

Education

Bachelor's degree or above

Tools

MS Office

Job description

PSI is seeking a motivated Study Startup Specialist I to join our Sydney, NSW team and help launch clinical trials from site contracts through to activation. You will collaborate with project teams and investigational sites, driving timelines, regulatory documentation, and site readiness to move studies efficiently from planning to execution.

Minimum 1 year in clinical development with start-up experience is required; strong English communication skills and proficiency in MS Office are