Study Startup Specialist I

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

Are you ready to play a key role in getting clinical trials off the ground? We are looking for a motivated clinical research professional to join our team and support the successful start-up of clinical studies in Australia. In this role, you will work closely with project teams and investigational sites, coordinating activities from site contracts and regulatory documentation through to site activation. This is a great opportunity for someone with clinical start-up experience who enjoys working across multiple stakeholders, taking ownership of timelines, and helping studies move efficiently from planning to execution.

• Maintain study-specific and corporate startup tracking systems
• Facilitate site budgets and contract negotiations
• Support site regulatory document collection
• Under supervision, may prepare initial/amendment submission dossiers to ethics committees, and/or site submission dossiers (as applicable)
• Communicates with the project team and investigational sites throughout the study lifecycle
• Develop site specific startup timelines and enrollment projections and is responsible for meeting the site activation milestones
• May review study specific translations
• Responsible for maintaining the Trial Master File (TMF) for assigned tasks throughout the study lifecycle

• Minimum of 1 years of experience in clinical development including start up process experience
• Experience with EC submissions
• 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 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 they're 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.