Remote Clinical QC Manager - Risk-Based Trial Oversight

Zai Lab (US) LLC; South San Francisco (CA); Remote; USD 140,000 - 160,000; Full time

Job summary

Zai Lab (US) LLC is seeking a Clinical QC Manager to oversee independent QC assessments ensuring trials comply with study protocols, GCP, and company procedures. This role involves on-site visits, risk-based reviews, and collaboration with CTMs, CRAs, and Clinical Operations staff to verify critical activities are conducted as intended.

Based remotely with frequent travel to investigational sites, you will identify protocol adherence gaps, support CAPA, and participate in cross-site oversight.

Qualifications

• Bachelor’s degree in medical science or related field with five years’ clinical research experience.
• Experience with QC oversight and inspection-related activities.
• Strong knowledge of ICH-GCP and applicable regulations.

Responsibilities

• Plan, conduct, and report QC assessments and visits to investigational sites.
• Identify protocol deviations, risks, and CAPA; track follow-up actions.
• Support inspection readiness through readiness reviews and targeted site/document reviews.
• Contribute to training and process improvements based on QC findings and regulatory feedback.

Skills

QC oversight

Regulatory knowledge

Communication

Education

Bachelor’s degree in medical science

Job description

Zai Lab (US) LLC is seeking a Clinical QC Manager to oversee independent QC assessments ensuring trials comply with study protocols, GCP, and company procedures. This role involves on-site visits, risk-based reviews, and collaboration with CTMs, CRAs, and Clinical Operations staff to verify critical activities are conducted as intended.

Based remotely with frequent travel to investigational sites, you will identify protocol adherence gaps, support CAPA, and participate in cross-site oversight.