Job Description

Take your career to the next level and lead the challenging study activation process in Australia. You will support clinical research teams and ensure PSI projects start smoothly and on time.

We’re looking for a SSU Specialist on a 12-month contract to support our increased workload. This is a great opportunity for someone looking to gain hands‑on experience in clinical research or transition into a Study Startup role. Our office is based in Macquarie Park, Sydney.

You Will

- 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 (as applicable)
- 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

Qualifications

- At least 1 year industry experience in clinical research and/or a minimum 1 year of Study Startup experience in Australia
- 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)

Culture And Perks

- A hybrid work arrangement with two flexible work‑from‑home days and three on‑site days each week.
- Our office is located in Macquarie Park and we offer onsite parking for your convenience.
- Opportunities for learning and career development.
- Access to mental wellness programs.
- Novated leasing options.
- The chance to work within a meaningful industry in a global organization setting.

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📌 Study Startup Specialist II (12-months contract) (City of Sydney)
🏢 Psi Cro
📍 City of Sydney