Senior Study Startup Specialist

Take your career to the next level and be involved in study startup processes in the UK. You will provide direct operational support to project teams, ensure that clinical projects start smoothly and on time and support PSI in developing the local study startup team.

This role is hybrid with 2 days based in our Oxford office.

• 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.
• Compile IP-REDs packages assuring high quality.
• Review study-specific translations, including patient-facing documents.
• Facilitates site agreement and/or budget negotiations with sites to ensure alignment to the site activation plan.
• Ensure initial distribution of locally obtained c...