Study Startup / Site Activation Specialist - Temporary position

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

You will mainly: 

• Lead finalization of site/vendor agreements and budgets negotiation to ensure alignment to the study activation plan
• Customizes and prepare country- site-specific and vendor agreements and agreement amendments
• Prepare and track the status of site and vendor agreements, budget negotiation, and coordinates the signature process

Additionally, you will:

• Coordinates study startup activities with the local project team and supports all processes critical for site activation.
• Collaborate with the project team for site activation processes
• Assist in feasibility research and site identification
• Collect site documents for IRB/IEC submission and/or IP-RED process
• Identify and escalate project-specific issues as needed
• Prepare and submit the study dossiers to sites, competent authorities, IRBs/IECs
• Prepare IP-REDs packages
• Support initial distribution of Investigational Product(s) and 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
• Train and coach department staff on startup processes

***Note, this is a temporary position for a period of 6-10 months***