Manager, Clinical Study Start-Up

📋 Description

• Lead a team supporting study and site start-up execution, amendment submissions and approvals
• Lead or supervise development of study start-up materials and study documents (e.g., consent
• Lead and oversee preparation and negotiation of initial clinical trial budgets and budget
• Oversee timely registration, maintenance, results reporting, and closure of clinical studies in
• Provide periodic updates to management on site start-up progress, communicate delays, and propose
• Establish, monitor, and report study start-up performance and quality metrics to drive corrective

🎯 Requirements

• Bachelor's degree in Biology, Nursing, Biomedical or Physical Sciences or related field with 7+
• 3+ years’ experience in operational aspects of managing clinical studies from start-up to
• Knowledge of ICH-GCPs, 21 CFR, and other relevant regulations and standards
• Experience creating and negotiating clinical budgets and contracts
• Extensive clinical research knowledge and cross-functional understanding of clinical trial
• Medical device experience desirable

🎁 Benefits

• Collaborative teamwork environment with constant learning
• Opportunity to be part of a team revolutionizing treatment of devastating diseases
• Medical, dental, vision, life, AD&D insurance
• Short and long-term disability insurance
• 401(k) with employer match
• Paid parental leave