About Us

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3,000 driven, dedicated, and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

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.

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Job Description

Take your career to the next level and lead challenging study activation processes on a country level. You will support clinical research teams and ensure PSI projects start smoothly and on time.

You will:

• Perform study startup activities and support all processes critical for site activation
• Collect site documents for IRB/IEC submission and/or IP-RED process
• File study-specific documentation in TMF, in accordance with Document management plan
• Assist in feasibility research and site identification, upon request
• Facilitate site agreement and budget negotiations
• Coordinate translation and review of study-specific documents
• Identify and escalate project-specific issues as needed
• Prepare and submit IP-REDs packages
• Ensure initial distribution of locally obtained clinical study supplies to sites and supervises initial distribution of Investigational Product(s) and centrally obtained clinical study supplies to sites
• Ensure exchange of information and documentation with investigational sites, off site facilities and vendors
• Participate in development of site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets under supervision