Clinical Operations Manager

Overview

• Lead operational performance of clinical research staff, ensuring protocol compliance and patient safety.
• Coordinate clinical research activities adhering to ICH, GCP, and FDA guidelines.
• Provide leadership and oversight to enhance study performance and efficiency.
• Collaborate across departments to meet study milestones and deliver quality data.
• Oversee staff assignments, resource allocation, and performance monitoring.
• Ensure compliance with SOPs, regulatory standards, and company policies.
• Develop and execute corrective action plans to address emerging risks.
• Support training initiatives for protocol specifics and operational guidelines.
• Participate in strategic meetings and contribute to organizational goals.

Key Responsibilities & Duties

• Manage clinical research staff and ensure operational alignment with study protocols.
• Monitor performance dashboards and oversee site and patient activities.
• Coordinate with departments to achieve study activation and enrollment targets.
• Ensure timely execution of operational aspects and data updates.
• Conduct training on clinical plans, SOPs, and timelines for staff.
• Oversee compliance with regulatory standards and company policies.
• Manage staff activities, including performance appraisals and career coaching.
• Collaborate with investigators to ensure patient safety and study goals.
• Present findings and updates in management and site meetings.

Job Requirements

• Bachelor’s degree in Science or equivalent education and experience.
• Minimum 2 years of clinical research experience, including CRC roles.
• Preferred 1+ years of management experience in clinical research.
• Proficiency in English and Spanish is advantageous.
• Strong organizational, project management, and problem-solving skills.
• Proficiency with Microsoft applications and electronic health records.
• Ability to handle sensitive information confidentially and professionally.
• Familiarity with HIPAA guidelines and regulatory compliance.
• Demonstrated ability to work independently and collaboratively.