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)