Site Manager

Overview

• Lead operational performance and clinical research activities at a dynamic research site.
• Provide bilingual Spanish/English oversight to ensure patient safety and protocol compliance.
• Manage and develop a team of 14 staff members for optimal site operations.
• Collaborate with department leaders to meet study milestones and deliver quality data.
• Ensure adherence to ICH guidelines, GCP, FDA regulations, and company policies.
• Drive strategic initiatives and implement risk mitigation strategies effectively.
• Participate in management meetings and present operational updates.
• Contribute to the success of clinical trials through proactive leadership and problem-solving.

Key Responsibilities & Duties

• Oversee site management and leadership to enhance efficiencies and compliance.
• Coordinate with investigators to ensure patient safety and study goals are met.
• Monitor performance dashboards and clinical trial systems for timely execution.
• Manage site staff, including hiring, training, and performance evaluations.
• Ensure compliance with SOPs, GCP, FDA regulations, and company policies.
• Develop corrective action plans to address emerging risks at site and study levels.
• Collaborate with departments to meet budgets and study deliverables.
• Provide ongoing training for staff on protocol specifics and clinical guidelines.
• Present updates and participate in strategic planning discussions.

Job Requirements

• Bachelor’s degree in science or equivalent education and experience required.
• Minimum 5 years of clinical research experience, with 2 years in site management.
• Bilingual proficiency in Spanish and English is mandatory.
• Proficiency in Microsoft applications, electronic health records, and web applications.
• Strong organizational, problem-solving, and project management skills.
• Ability to handle sensitive information confidentially and professionally.
• Effective communication and interpersonal skills for collaboration.
• Self-motivated, professional demeanor with a strong work ethic.
• Knowledge of HIPAA guidelines and clinical trial regulations.