Study Startup Specialist I

Study Startup Specialist IFull-timeCompany DescriptionPSI 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 DescriptionAre 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:Maintain study-specific and corporate startup tracking systemsFacilitate site budgets and contract negotiationsSupport site regulatory document collectionUnder 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 lifecycleDevelop site specific startup timelines and enrollment projections and is responsible for meeting the site activation milestonesMay review study specific translationsResponsible for maintaining the Trial Master File (TMF) for assigned tasks throughout the study lifecycleQualificationsMinimum of 1 years of experience in clinical development including start up process experienceExperience with EC submissionsBachelor’s degree or above, preferred in pharmaceutical/healthcare related majorsExcellent communication skills, both written and verbalFull working proficiency in EnglishProficiency in MS Office (Word, Excel, PowerPoint, Outlook)Additional InformationCulture And BenefitsWe 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.Growth OpportunitiesPSI 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.By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy applyI'm interestedI'm interestedPrivacy Notice