Clinical Research Operations Manager

Overview

• Lead operational performance of clinical research staff, ensuring compliance with ICH guidelines, GCP, FDA regulations, and company policies.
• Provide on-site oversight to coordinate clinical research activities and ensure protocol adherence and patient safety.
• Collaborate with cross-functional teams to meet study milestones, budgets, and deliver quality data to sponsors.
• Oversee resourcing allocations, site assignments, and study team performance to ensure deliverables are on track.
• Assist with training on protocols, SOPs, clinical plans, and timelines for effective study execution.
• Ensure adherence to regulatory requirements and company policies through routine assessments and corrective actions.
• Employ strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Participate in management meetings and present findings to stakeholders as needed.

Key Responsibilities & Duties

• Drive study performance, enhancing efficiencies, patient safety, and protocol compliance.
• Coordinate with departments to meet study milestones and deliver quality data.
• Review dashboards and systems to oversee site activities and ensure timely execution.
• Manage site staff, ensuring adherence to processes and training compliance.
• Develop corrective action plans and oversee their execution at site and study levels.
• Handle people management activities, including training, performance appraisals, and career coaching.
• Collaborate with investigators to ensure patient safety and meet project goals.
• Implement risk mitigations and propose solutions to emerging challenges.

Job Requirements

• Bachelor’s degree in science or equivalent combination of education and experience.
• Minimum of 2 years in clinical research, with 1+ years of management experience preferred.
• Proficiency in Microsoft applications, electronic health records, and web applications.
• Strong organizational, time management, problem-solving, and project management skills.
• Excellent written and verbal communication skills, with interpersonal and listening abilities.
• Ability to handle sensitive information confidentially and professionally, adhering to HIPAA guidelines.
• Self-motivated, professional, and respectful with a high degree of integrity and dependability.
• Bilingual proficiency in English and Spanish is a plus.