Study Startup specialist I

PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Originating from 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. If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you This is a hybrid position with 2 days per week in the Oxford office Job Description Supports all processes critical for site activation Supports Feasibility department with feasibility research and site identification process Maintains study-specific and corporate startup tracking systems Facilitates site budgets and contract negotiations Supports site regulatory document collection Under supervision, may prepare initial submission dossiers to competent authorities, ethics committees, and/or site submission dossiers (as applicable) Communicates with the project team and investigational sites throughout the study startup phase 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 1 year industry experience in clinical research and/or a minimum 1 year of Study Startup experience in the country/region. Bachelor’s degree or above, preferred in pharmaceutical/healthcare related majors Excellent communication skills, both written and verbal Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) #J-18808-Ljbffr