Director of Clinical Operations

Job Title: Director of Clinical Operations

Work Location: Miami-Dade County, Florida

Summary:

Seeking an experienced operational leader to oversee and optimize clinical research site operations, drive study execution, and ensure regulatory compliance. This role is responsible for managing performance metrics, supporting site teams, and implementing scalable processes to enable growth and operational excellence across a clinical research network.

Responsibilities:

• Direct daily operations across multiple clinical research sites, ensuring consistency in workflows, staffing, and study execution standards.
• Monitor key performance indicators such as enrollment, screening, visit completion, and study timelines, implementing process improvements as needed.
• Ensure all clinical trials are conducted in compliance with ICH-GCP, FDA regulations, and internal SOPs, supporting site readiness for new studies.
• Collaborate with recruitment teams to optimize enrollment, track recruitment metrics, and address operational barriers to participant recruitment.
• Promote a culture of regulatory compliance and operational quality, ensuring readiness for audits, inspections, and sponsor monitoring visits.
• Develop and implement standardized operational processes, dashboards, and reporting tools to support scalable site operations.
• Provide leadership and support to site managers and clinical teams, establishing performance expectations and fostering a collaborative, high-performance culture.
• Support operational planning for new site launches and network expansion, ensuring readiness for new therapeutic areas and study types.

Qualifications:

• Bachelor’s degree in life sciences, healthcare administration, or a related field.
• 8+ years of clinical research experience, preferably in site operations.
• 3–5 years of leadership or management experience in clinical research or healthcare operations.
• Strong understanding of ICH-GCP, FDA regulations, and clinical trial site operations.
• Experience working in multi-site clinical research environments preferred.
• Demonstrated ability to manage operational performance and drive process improvement.
• Excellent leadership, organizational, and communication skills.
• Preferred: Experience in CNS clinical trials or behavioral health research; experience with site networks or site management organizations (SMOs).

Published Category: Clinical Operations & Development