Senior Site Start-Up Associate

Job Summary

To support biotech, medtech, and specialty pharma companies, the full-time remote Senior Site Start-Up Associate will manage quality deliverables for study start-up, forecast submission timelines, and prepare necessary regulatory applications and approvals.

Key responsibilities

• Takes responsibility for quality deliverables at the country level for study start-up, adhering to project requirements and local regulations
• Forecasts submission and approval timelines, providing contingency plans for delays and serving as the primary contact for project stakeholders
• Prepares and submits Central EC/IRB Applications and other regulatory submissions while resolving any issues at the country level

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 2 with at least 7 years of relevant experience, including 5 years in clinical trial application submissions
• Broad experience with various study types and phases, including interventional and non-interventional studies
• Thorough knowledge of FDA Guidance Documents, EU Directives, and local regulatory requirements for clinical trials
• Expertise in ICH/GCP and local regulatory authority drug research and development regulations