Clinical Operations Manager

Barrington James; Miami (FL); On-site; USD 180,000 - 240,000; Full time

Job summary

Barrington James is seeking a Director/Manager of Clinical Operations, Phase I in Miami to oversee clinical trials, ensure protocol adherence, and manage staff and operational aspects of studies. The role demands strict compliance with GCP, ICH guidelines and company SOPs.

Core duties include staff management, protocol review, quality assurance and study supervision, with collaboration across PIs and Site Directors to optimize enrollment and site performance.

Qualifications

• Bachelor's degree in a scientific or healthcare-related field.
• Phase I or early phase clinical operations experience.
• 7–10 years in clinical operations, with 5+ years in a senior leadership role.
• Strong knowledge of FDA, ICH and GCP regulations.
• Excellent communication, organizational and leadership abilities.
• Proficiency with Microsoft Word, Excel, and CTMS.
• Experience mentoring a clinical operations team and bilingual in English and Spanish.

Responsibilities

• Lead and mentor the clinical operations team and foster collaboration.
• Ensure protocol compliance and high-quality study standards.
• Partner with Principal Investigators and 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 regulators.
• Coordinate with Site Director and PIs to assign coordinators.
• Review study components with PIs and Site Directors before initiation.
• Conduct study closeout procedures.
• Ensure compliance with FDA, ICH, and GCP regulations.

Skills

Leadership

Communication

Organizational skills

Bilingual English and Spanish

Education

Bachelor's degree in science or healthcare

Tools

Microsoft Word

Microsoft Excel

Clinical trial management software

Job description

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