Manager – Clinical Operations Full Time NEW

Responsibilities

• Lead aspects of clinical studies and perform vendor management
• Accountable for delivering projects on time, scope, quality, and budget
• Manage vendor and site contracts, budgets, and TMF activities
• Ensure oversight of patient enrollment, site activation, and data collection
• Support completeness of clinical protocol, informed consent forms, and reports
• Ensure accuracy and thoroughness of site monitoring reports
• Support efficient database lock through monitoring plans and data review
• Coordinate with Clinical Supply Chain for drug forecasting and supply
• Identify risks and broker solutions for clinical studies
• Mentor junior team members and support their development
• Lead or co-lead department initiatives and projects
• Travel may be required (10%–15%)

Requirements

• Bachelor’s degree in a scientific or healthcare discipline preferred
• 3-5 years of experience in clinical research or clinical operations
• Knowledge of ICH-GCP guidelines
• Relevant experience in managing early through late Phase clinical trials
• Knowledge of oncology clinical trials preferred
• Experience managing international clinical trials preferred
• Cross-functional leadership and communication skills
• Capability to challenge status-quo with a risk management approach