Study Startup Specialist I

PSI CRO; Sydney; Hybrid; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work arrangement

Onsite parking

Learning and professional development

Mental wellness programs

Novated leasing options

Job summary

PSI is a leading CRO with a global footprint and a strong presence in Australia. We seek a clinical research professional to support start-up activities for Australian studies, coordinating with project teams and sites from contracts to activation.

This role offers ownership of timelines and cross-functional collaboration in a dynamic, quality-driven environment. You will maintain start-up trackers, assist with regulatory dossiers, and ensure TMF quality while working in a hybrid setup with two

Qualifications

• Minimum of 1 year of experience in clinical development including start-up process
• 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)

Responsibilities

• 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
• Communicates with the project team and investigational sites throughout the study lifecycle
• Develop site specific startup timelines and enrollment projections and be 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

Skills

Clinical start-up experience

Regulatory submissions experience

English proficiency

Communication skills

Education

Bachelor’s degree or above, pharmaceutical/healthcare preferred

Tools

MS Office

Job description

PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.

At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.

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.

You will:

• Maintainstudy-specific and corporate startup tracking systems
• Facilitatesite budgets and contract negotiations
• Supportsite 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
• Developsite specific startup timelines and enrollment projections and is responsible for meeting the site activation milestones
• May review study specific translations
• Responsible for maintaining theTrial Master File (TMF) for assigned tasks throughout the study lifecycle

Qualifications

• 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)

Additional Information

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 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.

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.