Topography Health is hiring a
Clinical Quality Manager, Remote - Worldwide

Summary

The job description is for a Clinical Quality Manager who will lead the clinical quality assurance team, ensuring compliance with regulatory requirements and maintaining high standards of quality in clinical trials. The role involves monitoring data quality, conducting internal audits, developing quality programs, and serving as a key communication conduit between study sites and the clinical operations management team.

Requirements

• Bachelor's Degree in a related field (e.g., Life Sciences, Regulatory Affairs, Quality Management) or equivalent 4 years of work experience
• 5+ years of experience in quality and regulatory roles within the clinical trials, pharmaceutical, or healthcare technology sectors
• 3+ years of experience leading a cross-functional team
• Ability to travel up to 50% of the time

Responsibilities

• Establish and maintain our quality program
• Develop and implement quality management systems
• Draft and manage Quality Management Standard Operating Procedures (SOPs)
• Develop, manage, and execute the Corrective and Preventive Action (CAPA) process
• Develop, manage, and execute internal data monitoring plans and data quality reviews
• Conduct 10% Data Quality Reviews
• Develop, manage, and execute eligibility reviews
• Ensure adherence to ICH-GCP guidelines, FDA regulations, and other applicable regulatory requirements
• Ensure adherence to study protocols and proactively address site performance issues
• Verify the accuracy of clinical data and manage any data discrepancies
• Serve as a key communication conduit between study sites and the clinical operations management team
• Manage oversight and accountability for timely reporting to external parties
• Foster a culture of continuous improvement, leading initiatives to enhance efficiency, quality, and compliance across the organization
• Serve as a point of escalation for the company on quality matters
• Conduct and oversee vendor qualification visits
• Maintain the company level training matrix to ensure 100% training compliance across the organization
• Establish and maintain an annual audit plan of all Topography clinical sites
• Be prepared to make training, resource, or performance evaluation recommendations based upon quality assurance findings
• Serve as the main point of contact and internal owner of the quality management system
• Direct line management of QA team members
• Direct supervision of all sponsor and/or FDA site audits
• Oversight of ensuring all Topography sites are audit ready at all times
• Any other duties as assigned by manager

Preferred Qualifications

• Professional certification in clinical research (e.g., SOCRA, ACRP)
• Located on the East Coast
• Experience as a Clinical Research Coordinator