Sr Clinical Study Manager

📋 Description

• Develops/maintains project timelines from startup to completion.
• Drives development and distribution of study documents and tools.
• Manages regulatory documentation and audit readiness at sites and HQ.
• Negotiates study budgets with sites, Core Labs, and vendors.
• Attends site visits (initiation, monitoring, close-out).
• Leads complex US/OUS clinical projects; monitors progress and data.

🎯 Requirements

• Bachelor's in Biological Sciences or related field; 7+ years.
• 7+ years of relevant clinical trial experience.
• PM experience: at least 1 clinical project and 1 multicenter US/OUS trial.
• Proficiency with MS Project, MS Office, EDC Systems, and vendor oversight.
• Familiar with CFR and GCP/ICH requirements; medical terminology.
• Excellent communication and organizational skills; English fluency.

🎁 Benefits

• Collaborative, learning-focused team.
• Opportunity to contribute to innovative therapies.
• Generous benefits: medical, dental, vision, life.
• 401(k) with employer match; parental leave.
• Paid holidays and vacation; sick time.