💼 About This Role

You'll serve as the unblinded point of contact for sites, vendors, and CROs, ensuring compliance with ICH-GCP and regulations in a late-stage biopharmaceutical company. Your work will support the development of a novel SMA therapy with highly innovative anti-myostatin programs.

🎯 What You'll Do

• Serve as primary unblinded point of contact for sites and CROs
• Review temperature excursions and resolve inventory non-conformances
• Conduct unblinded co-monitoring visits per Sponsor Oversight Plan
• Track KPIs to assess CRO and site performance

📋 Requirements

• BS/BA in a scientific discipline
• 3+ years in biotech/pharma/CRO clinical research
• Multi-phase clinical program experience
• Knowledge of ICH-GCP and regulatory requirements

✨ Nice to Have

• Advanced degree preferred
• Experience with IRT and UAT

📨 Hiring Process

Estimated timeline: 3-5 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 1 hour
3. 3Panel Interview· 1.5 hours