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About the Role
Support the successful start-up of clinical studies in Australia by coordinating activities from site contracts and regulatory documentation through to site activation. This role involves working closely with project teams and investigational sites, managing timelines, and ensuring efficient study execution.
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 (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
Requirements
- Minimum of 1 years of experience in clinical development including start up process experience
- Experience with EC submissions
- Full working proficiency in English
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook)
Skills
- Excellent communication skills, both written and verbal
Location
- Australia
Work Type
- Hybrid work arrangement
- Onsite
- Remote
Experience Level
- Minimum of 1 years of experience
Education Level
- Bachelor’s degree or above, preferred in pharmaceutical/healthcare related majors
Benefits
- A hybrid work arrangement with two flexible work-from-home days and three on-site days each week
- Onsite parking
- 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
About the Company
- 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.
- 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.