Clinical Trials Quality & Compliance Manager - Remote

Overview

The Clinical Trials Quality & Compliance Manager will lead the oversight of regulatory compliance, training, and quality systems across all CVAUSA research practices, ensuring every site is prepared and every process is sound.

In Short

• Drive audit readiness for clinical trials.
• Conduct oversight through routine and for-cause audits.
• Lead regulatory processes including IRB submissions.
• Design and deliver training programs for site staff.
• Establish startup processes for new sites.
• Embed quality systems for data integrity.
• Support and mentor research teams in compliance.
• Communicate effectively across multiple practices.
• Build a culture of accountability and quality.
• Travel to CVAUSA practices as needed.

Requirements

• 5+ years of experience in regulatory compliance for clinical trials.
• Strong knowledge of ICH-GCP and FDA regulations.
• Hands-on experience with site-level audits.
• Expertise in training program design.
• Experience developing SOPs and compliance frameworks.
• Excellent communication and leadership skills.
• Self-starter with a focus on compliance processes.

Benefits

• Opportunity to lead quality initiatives in clinical trials.
• Flexible remote work with travel opportunities.
• Collaborative environment with a focus on excellence.
• Impactful role in building trust and integrity in clinical research.
• Supportive team and resources for professional growth.