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 outstanding 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 Benefits
A hybrid work arrangement with two adaptable 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.
Prospects for learning and professional 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 New South Wales
🏢 Psi Cro
📍 New South Wales