Clinical QC Manager- Hybrid

Primary Function:

The Clinical QC Manager is a Clinical Operationsbased 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 riskbased QC oversight through onsite 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 followup actions. The role identifies protocol adherence gaps recurring operational issues and process risks and supports timely followup 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 onsite QC visits and assessments.

Major Responsibilities and Duties:

QC Planning Assessments and Reporting

• Develop and maintain studyspecific 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 riskbased onsite QC visits to investigational sites to assess protocol adherence and execution of critical study processes (e.g. informed consent process checks protocolrequired procedures safety reporting processes and essential document maintenance).
• Conduct inhouse QC activities (remote or inoffice 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 followup actions.
• Escalate significant compliance patient safety or data integrity concerns through defined Clinical Operations escalation pathways.

Issue Identification FollowUp and Trend Analysis

• On a regular basis in partnership with Clinical Operations teams identify protocol deviations recurring sitelevel 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 followup actions to closure and contribute to crosssite and crossstudy trend analysis.

Inspection Readiness Support

• Support inspection readiness activities across preparation conduct and followup phases including selfchecks 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.

Training Knowledge Sharing and Operational Improvement

• 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.

Qualifications :

REQUIRED:

• Bachelors degree in medical science or a related field with five years experience in clinical research including handson experience with qualityrelated activities such as QC oversight and inspectionrelated activities; or equivalent combination of higher education training and experience.

PREFERRED:

• Deep knowledge and understanding of clinical trial processes and quality management.
• Strong working knowledge of ICHGCP 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.

Additional Information :

The pay range for this position at commencement of employment is expected to be between $145K and $170K/year; however base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and experience. The total compensation package for this position may also include other elements including a sign-on bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

At Zai we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels 58% of our employees are women and 54% of our management positions are held by women. We are committed to the health of patients and our planet. Thats why our environmental protection social responsibility and corporate governance strategy called Trust for Life is integrated within our business.

Disclaimer: This description is not intended to be construed as an exhaustive list of duties responsibilities or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time as needed.

All qualified applicants will receive consideration for employment without regard to race sex color religion sexual orientation gender identity national origin protected veteran status or based on disability.

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Remote Work :

No

Employment Type :

Full-time