Site Start-up Associate II

Job Summary

A company is looking for a Site Start up Associate II to join their Global SSU team.

Key Responsibilities

• Ensure quality deliverables at the country level for study start-up, adhering to project requirements and local regulations
• Forecast submission/approval timelines, address delays, and serve as a primary contact for project stakeholders during start-up
• Prepare and submit various regulatory applications and manage ongoing submissions and notifications as required by local authorities

Required Qualifications

• Undergraduate degree or equivalent in a clinical, science, or health-related field, or a licensed healthcare professional
• Proven experience as a SSUA Level 1 and/or 5+ years of relevant experience, including at least 3 years as a SSUA or in clinical trial application submissions
• Experience with various study types/phases, including interventional and non-interventional studies
• Experience leading larger programs through the start-up phase
• Essential experience in contract preparation