Clinical Trial Quality Control Manager – Site Oversight

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🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $140k - $160k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Zai Lab

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2014

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $857.5M Post-IPO Equity on 2021-04

Healthcare • Biotechnology • Pharmaceuticals

Zai Lab is an innovative, research-based, commercial stage biopharmaceutical company based in China and the U. S. focused on bringing transformative medicines for oncology, immunology, neuroscience, and infectious diseases to patients in China and around the world. Their mission is to provide innovative treatments to patients with unmet medical needs, significantly impacting global health.

📋 Description

• 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