Manager, Clinical Trials

📋 Description

• Manage execution of complex clinical studies to meet timelines, cost and quality.
• Select and manage vendors/CROs to ensure compliance, budget and timelines.
• Oversee contracting, budgeting, forecasting, accruals and payments for vendors/sites.
• Lead protocol and consent prep, investigator selection, training, CRFs and TMF.
• Collaborate with Clinical Data Management to ensure CRF content and data listings.
• Train CROs, vendors and staff on the study protocol and monitor progress.

🎯 Requirements

• Bachelor’s in life sciences; advanced degree preferred.
• 8+ years in clinical research; 4+ years leading trials.
• 4-7 years supporting trials in regulated environments.
• Experience managing CROs.
• Knowledge of FDA regulations, ICH-GCPs, and SOPs.
• Proficient in MS Word, Excel and PowerPoint. Strong organization.
• Leadership, communication, and planning skills.

🎁 Benefits

• Comprehensive medical, dental, vision, life coverage.
• Fertility care benefits.
• Pregnancy and baby bonding leave.
• 401(k) and commuter benefits.
• Generous employee referral program.