Clinical Trial Quality Control Manager – Site Oversight

This is a fully remote position, open to applicants in California.

📋 Description

• Develop and uphold study-specific quality control (QC) plans tailored to study progression, complexity, and risk evaluation.

• Design and manage QC tools, including checklists, templates, and tracking systems.

• Perform risk-based, on-site QC visits to investigative sites.

• Evaluate adherence to protocols and execution of critical study processes such as informed consent, protocol-required procedures, safety reporting, and maintenance of essential documents.

• Carry out in-house QC activities through remote or in-office reviews as necessary.

• Assess site processes and documentation.

• Prepare QC Visit Reports that detail scope, observations, trends, and follow-up actions.

• Report significant compliance, patient safety, or data integrity issues.

• Identify protocol deviations, recurring site-specific issues, and operational risks.

• Assist in root cause analysis and corrective and preventive action initiatives.

• Monitor QC findings and ensure follow-up actions are completed.

• Contribute to cross-site and cross-study trend analysis.

• Aid in inspection readiness activities, including self-assessments and targeted readiness reviews.

• Provide QC summaries and documentation to Clinical Operations leadership and study teams.

• Support Clinical Operations training initiatives based on QC findings and gaps in site execution.

• Integrate lessons learned into training, guidance, and communications for study teams.

• Recognize opportunities for process improvements.

• Assist in the implementation of standard operating procedures (SOPs) and study processes through training and clarification.

⛳️ Requirements

• A Bachelor’s degree in medical science or a related discipline, with a minimum of five years’ experience in clinical research, including practical quality-related activities such as QC oversight and inspection-related tasks; or a comparable combination of higher education, training, and experience.

• Extensive knowledge and understanding of clinical trial processes and quality management systems.

• Strong familiarity with ICH-GCP and relevant regulations and guidelines.

• Understanding of the skills and knowledge necessary for delivering clinical studies, encompassing international guidelines, study management, site management, and monitoring.

• Excellent communication and influencing abilities.

• Capability to analyze, interpret, and resolve complex issues.

• Strategic and objective thinking, creativity, innovation, and sound judgment.

• Dedication to maintaining high standards of integrity and ethics.

• Willingness to travel frequently to investigational sites.

🏝️ Benefits

• Sign-on bonus.

• Restricted stock units.

• Discretionary awards.

• Medical benefits.

• Financial benefits.

• 401(k) eligibility.

• Paid vacation time.

• Paid sick time.

• Paid parental leave.

• Remote work arrangements.