Director/Manager of Clinical Operations

Our client is seeking a Director/Manager of Clinical Operations, Phase I, to oversee clinical trials, ensure protocol adherence, and manage staff and operational aspects of studies. Requires strict compliance with GCP, ICH guidelines and company SOPs, with core duties spanning staff management, protocol review, quality assurance and study supervision.

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

Minimum qualifications

• 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, organisational 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