Clinical Trials Manager

Neurocrine Biosciences seeks a Clinical Trials Manager to oversee planning, execution, and closure of clinical studies across domestic and global programs. The role requires managing contract research organizations and internal study operations while ensuring compliance with FDA regulations and ICH guidelines.

Responsibilities

• Ensure assigned clinical studies comply with FDA regulations, EU Directive, ICH guidelines, and company SOPs
• Manage contract research organizations and service providers for assigned studies
• Lead study team meetings, develop timelines, identify enrollment barriers, and implement recruitment solutions
• Conduct or oversee clinical site monitoring, manage clinical research associates, and develop monitoring plans
• Serve as primary operational contact and participate in protocol and study design discussions

Requirements

• Bachelor's degree with 6+ years clinical trial management experience, or Master's with 4+ years related experience
• Detailed knowledge of clinical drug development, ICH guidelines, Good Clinical Practices, and FDA regulations
• Expertise in clinical operations from study startup through closeout
• Experience managing contract research organizations and vendors domestically and internationally
• Strong project management, leadership, and cross-functional collaboration skills
• Excellent analytical, problem-solving, and communication abilities
• Proficiency with computer systems and data analysis

Compensation: $130,800–$179,000 base salary, plus 30% target annual bonus and equity participation