Clinical QC Manager- Hybrid

Zai Lab (US) LLC•San Diego, CA

12d•Hybrid

About The Position

The Clinical QC Manager is a Clinical Operations–based role responsible for conducting independent quality control (QC) assessments to confirm that investigational sites are executing clinical trials in accordance with study protocols, GCP, and company procedures. This role performs targeted, risk‑based QC oversight through on‑site QC visits and focused documentation and process reviews to verify that critical study activities are being performed as intended. Working in partnership with Clinical Trial Managers (CTMs), CRAs, and other Clinical Operations staff, the Clinical QC Manager independently assesses site execution and protocol adherence and collaborates with the study team on follow‑up actions. The role identifies protocol adherence gaps, recurring operational issues, and process risks, and supports timely follow‑up with accountable owners. This position does not replace routine monitoring activities or serve as the primary site management function; rather, it strengthens study execution by evaluating site processes, identifying trends, and supporting issue resolution across studies. This position reports to the Executive Director, Head of US Clinical Operations, and is based in our South San Francisco, CA office. Frequent travel to investigational sites is required to support on‑site QC visits and assessments.

Requirements

Bachelor’s degree in medical science or a related field, with five years’ experience in clinical research, including hands‑on experience with quality‑related activities, such as QC oversight and inspection‑related activities; or equivalent combination of higher education, training and experience.

Nice To Haves

Deep knowledge and understanding of clinical trial processes and quality management.
Strong working knowledge of ICH‑GCP as well as applicable regulations and guidelines.
Solid understanding of the skills and knowledge required to deliver a clinical study (e.g., international guidelines, study management, site management, and monitoring).
Strong communication and influencing skills: able to communicate effectively and concisely, clearly articulate viewpoints, and align with stakeholders.
Demonstrated ability to analyze, interpret, and resolve complex issues.
Ability to think strategically and objectively, demonstrating creativity, innovation, and sound judgment.
Demonstrated commitment to the highest standards of integrity and ethics.

Responsibilities

Develop and maintain study‑specific QC plans, updating based on study progress, complexity, and risk assessment.
Create and maintain QC tools (e.g., checklists, templates, trackers) to support consistent execution of QC activities.
Conduct risk‑based, on‑site QC visits to investigational sites to assess protocol adherence and execution of critical study processes (e.g., informed consent process checks, protocol‑required procedures, safety reporting processes, and essential document maintenance).
Conduct in‑house QC activities (remote or in‑office reviews) as needed, ensuring QC activities are completed within defined timelines and quality expectations.
Evaluate site processes and documentation to confirm studies are being conducted consistently and as intended.
Prepare clear, objective QC Visit Reports documenting scope, observations, trends, and required follow‑up actions.
Escalate significant compliance, patient safety, or data integrity concerns through defined Clinical Operations escalation pathways.
On a regular basis, in partnership with Clinical Operations teams, identify protocol deviations, recurring site‑level issues, and operational risks through QC activities.
Support study teams with root cause analysis (RCA) and contribute to the development of corrective and preventive actions (CAPA), as needed.
Track QC findings and follow‑up actions to closure and contribute to cross‑site and cross‑study trend analysis.
Support inspection readiness activities across preparation, conduct, and follow‑up phases, including self‑checks and targeted readiness reviews.
Perform targeted reviews of site and study documentation as part of QC assessments to support ongoing inspection readiness.
Provide QC summaries and documentation to Clinical Operations leadership and study teams, as requested.
Contribute to training activities for Clinical Operations teams based on QC findings, common site execution gaps, and protocol adherence challenges.
Incorporate lessons learned from QC activities and regulatory inspections into training, guidance, and study team communications.
Identify opportunities for process improvement based on QC observations and trends.
Support implementation of applicable SOPs and study processes by reinforcing procedural expectations and providing training or clarification on relevant procedures.