Hybrid Clinical Study Start-Up Specialist

Psicro; Sydney; Hybrid; AUD 70,000 - 100,000; Full time

Benefits offered by this job

Hybrid work arrangement (2 WFH days)

Onsite parking

Learning and development

Mental wellness programs

Novated leasing options

Job summary

PSI is seeking a clinical start-up professional to drive site activation in Australia. You will coordinate between project teams and investigational sites, managing timelines, regulatory submissions, and TMF maintenance.

This hybrid role involves cross-functional collaboration and wearing multiple hats to ensure smooth startup execution. You will contribute to site budgets, contract negotiations, and regulatory document collection while coordinating with sites through the study lifecycle and

Qualifications

• Minimum of 1 year of experience in clinical development including start-up process experience.
• Experience with EC submissions.
• Excellent written and verbal communication skills.
• 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, prepare initial/amendment submission dossiers to ethics committees or site submissions.
• Communicate with project teams and investigational sites throughout the study lifecycle.
• Develop site startup timelines and enrollment projections and meet site activation milestones.
• May review study translations.
• Maintain the Trial Master File (TMF) for assigned tasks.

Skills

Communication

MS Office

English proficiency

Education

Bachelor's degree or above (pharma/healthcare)

Tools

MS Office Suite

Job description

PSI is seeking a clinical start-up professional to drive site activation in Australia. You will coordinate between project teams and investigational sites, managing timelines, regulatory submissions, and TMF maintenance.

This hybrid role involves cross-functional collaboration and wearing multiple hats to ensure smooth startup execution. You will contribute to site budgets, contract negotiations, and regulatory document collection while coordinating with sites through the study lifecycle and