Clinical Trials Quality Manager

Headlands Research Scottsdale!; United States; Remote; USD 80,000 - 100,000; Full time

Job description

Overview

At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and support services to broaden outreach and participation. Founded in 2018, our rapidly growing company operates 20+ sites across the US and Canada, with plans for expansion.

The Role

The Clinical Trials Quality Manager monitors the quality and consistency of data and clinical operations across network research sites in the US and Canada. This role ensures quality is integrated into all site processes and collaborates with Operations to verify outcomes. The position supports adherence to best practices, GCP, and regulatory standards.

We seek passionate employees committed to advancing healthcare and providing a safe, reliable, and compliant patient experience. Strong communication and deductive reasoning skills are essential. Experience in monitoring clinical research sites is preferred.

Responsibilities

• Develop and maintain SOPs, work instructions, and guidance documents in compliance with ICH-GCP and applicable regulations in the US and Canada.
• Review and update existing SOPs and guidance to ensure compliance and consistency.
• Support training development and delivery at the network and site levels.
• Conduct internal study reviews to ensure regulatory compliance, documenting findings and proposing corrective actions.
• Collaborate with operations to remediate issues and implement preventive measures.
• Participate in quality investigations and audits.
• Develop, implement, and monitor CAPAs within the region.
• Assess and report risks impacting sites.
• Review external site quality during M&A due diligence.
• Assist with the integration of new sites into the network.
• Share best practices to maintain inspection readiness.
• Attend audits and update leadership on findings.
• Track and support training of Headlands employees.
• Develop training materials for site staff.
• Support performance assessments, especially during probation.
• Engage in ongoing education on quality initiatives and regulations.
• Travel up to 30%, domestically and internationally.

Qualifications

• Certification by a professional clinical research organization preferred.
• Bachelor’s degree or equivalent; Associates Degree with 5 years of experience considered.
• Minimum 5 years in the clinical research industry.
• Strong knowledge of federal and local regulations and GCP.
• Adaptability from other cGXP environments.
• Extensive attention to detail.
• Effective communication and teamwork skills.
• Strong organizational skills.
• Ability to work independently or under supervision.
• Proficiency in MS Office.
• Ability to build rapport with colleagues and clients.