Site Manager

Overview

• Lead site operations to ensure clinical trial success and compliance with regulations.
• Collaborate across departments to meet study milestones and deliver quality data.
• Oversee performance dashboards and clinical trial systems for operational efficiency.
• Manage site staff, ensuring adherence to protocols and training compliance.
• Develop and execute corrective action plans to mitigate risks.
• Ensure compliance with GCP, FDA regulations, and company policies.
• Provide leadership and strategic direction for site management activities.
• Participate in management meetings and present operational updates.
• Drive patient safety and study deliverables through collaboration with investigators.

Key Responsibilities & Duties

• Coordinate study activities to achieve site activation and enrollment targets.
• Monitor site performance and escalate risks to timelines, quality, and budgets.
• Conduct training on protocols, SOPs, and clinical plans for site staff.
• Ensure timely execution of operational aspects through system updates.
• Manage site staff, including hiring, training, and performance evaluations.
• Collaborate with investigators to uphold patient safety standards.
• Develop strategic solutions to mitigate risks and improve efficiency.
• Ensure compliance with HIPAA guidelines and confidentiality standards.
• Participate in site meetings and contribute to operational planning.

Job Requirements

• Bachelor’s degree in a scientific field with 2+ years of clinical research experience.
• Minimum 2 years as a Clinical Research Coordinator; management experience preferred.
• Proficiency in Microsoft applications, EHR systems, and web applications.
• Strong organizational, time management, and problem-solving skills.
• Effective written and verbal communication and interpersonal skills.
• Ability to handle sensitive information confidentially and professionally.
• Self-motivated with a strong work ethic and professional demeanor.
• Bilingual proficiency in English and Spanish is a plus.
• Experience in site-level clinical research operations is essential.