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. 

Were 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

Qualifications :

• 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
• Bachelors 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)

Additional Information :

Culture And Benefits

We prioritize the well-being of our team and as part of our commitment we offer:

• 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 professional development.
• Access to mental wellness programs.
• Novated leasing options.
• The chance to work within a meaningful industry in a global organization setting.

How are we different

PSI is privately owned by the very people who founded the company more than 30 years ago and theyre still working here today. As a result we have grown organically around the globe and have kept our company fully independent giving us significant advantages and freedoms.  

Growth Opportunities

PSI is proud to invest in our people from entry-level team members to senior leaders helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs our professionals have a variety of opportunities to continue to grow throughout their career.

Remote Work :

No

Employment Type :

Full-time