Study Startup specialist I
PSI CRO
Company Description
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 DescriptionSupports all processes critical for site activationSupports Feasibility department with feasibility research and site identification processMaintains study-specific and corporate startup tracking systemsFacilitates site budgets and contract negotiationsSupports site regulatory document collectionUnder 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 phaseDevelops site specific startup timelines and enrollment projections and is responsible for meeting the site activation milestonesMay review study specific translationsSupervises Trial Master File (TMF) maintenance throughout the study startup phaseQualificationsAt 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 majorsExcellent communication skills, both written and verbalProficiency in MS Office (Word, Excel, PowerPoint, Outlook)
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