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 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)
What We Do
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
http://www.psi-cro.com
