Clinical Trial Quality Control Manager – Site Oversight
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Job Description
Clinical QC Manager overseeing investigational-site quality for Zai Lab, a biopharmaceutical company developing medicines for oncology and other diseases. Conducting risk-based site assessments, inspection-readiness reviews, trend analysis, and corrective-action follow-up.
Responsibilities:
- Develop and maintain study-specific QC plans based on study progress, complexity, and risk assessment
- Create and maintain QC tools, including checklists, templates, and trackers
- Conduct risk-based, on-site QC visits to investigational sites
- Assess protocol adherence and execution of critical study processes, including informed consent, protocol-required procedures, safety reporting, and essential document maintenance
- Conduct in-house QC activities through remote or in-office reviews as needed
- Evaluate site processes and documentation
- Prepare QC Visit Reports documenting scope, observations, trends, and follow-up actions
- Escalate significant compliance, patient safety, or data integrity concerns
- Identify protocol deviations, recurring site-level issues, and operational risks
- Support root cause analysis and corrective and preventive actions
- Track QC findings and follow-up actions to closure
- Contribute to cross-site and cross-study trend analysis
- Support inspection readiness activities, including self-checks and targeted readiness reviews
- Provide QC summaries and documentation to Clinical Operations leadership and study teams
- Contribute to Clinical Operations training based on QC findings and site execution gaps
- Incorporate lessons learned into training, guidance, and study team communications
- Identify process improvement opportunities
- Support implementation of SOPs and study processes through training and clarification
Requirements:
- Bachelor’s degree in medical science or a related field, with five years’ experience in clinical research, including hands-on quality-related activities such as QC oversight and inspection-related activities; or equivalent combination of higher education, training and experience
- Deep knowledge and understanding of clinical trial processes and quality management
- Strong working knowledge of ICH-GCP and applicable regulations and guidelines
- Understanding of skills and knowledge required to deliver clinical studies, including international guidelines, study management, site management, and monitoring
- Strong communication and influencing skills
- Ability to analyze, interpret, and resolve complex issues
- Strategic and objective thinking, creativity, innovation, and sound judgment
- Commitment to high standards of integrity and ethics
- Frequent travel to investigational sites required
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 arrangement
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