Clinical Operations Manager

About the role

Oversee clinical trials, ensure protocol adherence, and manage staff and operational aspects of Phase I studies. Requires strict compliance with GCP, ICH guidelines, and company SOPs.

Responsibilities

• Lead and mentor the clinical operations team, fostering a collaborative and efficient environment
• Ensure protocol compliance and maintain high quality standards across studies
• Partner with Principal Investigators and the Site Director to assign studies and develop enrollment strategies
• Oversee HR functions including staff evaluations, recruitment, and training
• Monitor protocol adherence and report deviations to sponsors and regulatory bodies
• Coordinate with the Site Director and Principal Investigators to assign clinical research coordinators
• Review study components with PIs and Site Directors ahead of study initiation
• Conduct study closeout procedures
• Ensure compliance with FDA, ICH, and GCP regulations

Requirements

• Bachelor's degree in a scientific or healthcare related field
• Phase I or early phase experience
• 7-10 years of clinical operations experience, including 5+ years in a senior leadership role
• Strong understanding of FDA, ICH, and GCP regulations and guidelines
• Strong communication, organizational, and leadership skills
• Proficiency in Microsoft Word, Excel, and clinical trial management software
• In-depth knowledge of clinical trial operations, including study start-up, site selection, patient recruitment, monitoring, data management, and study close-out
• Experience managing and mentoring a team of clinical operations professionals
• Bilingual in English and Spanish