Study Startup Specialist II (18-months contract)

Take your career to the next level and lead 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 Study Startup Specialist II to join our team on an 18-month contract to support increased project demands. This newly created role is an excellent opportunity for someone looking to gain hands-on experience in clinical research or transition into a Study Startup position. To be considered, you must be based in Sydney and able to meet our current hybrid working arrangement.
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
At least 2 years of industry experience in clinical research as a Study Startup Specialist, or similar position with practical study startup experience in the 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)

Employment type
Full-time

Work arrangement
Hybrid