Clinical Operations Manager (Office Based - South SF 3X/wk)

Zai Lab (US) LLC • South San Francisco, CA

5h • Hybrid

About The Position

The Clinical Operations Manager is responsible for the oversight and performance management of Clinical Research Associates (CRAs) to ensure high-quality execution of clinical trials in compliance with ICH-GCP, SOPs, and regulatory requirements. This role serves as the primary operational lead for CRAs and ensures monitoring activities support study timelines, data integrity, and patient safety.
This hybrid role is based in our South San Francisco, CA office.

Requirements

• Bachelor’s degree in life sciences, nursing, or a related field with six years clinical research experience of which four years are as a CRA with strong monitoring expertise
• Proven leadership experience in people management or mentoring (direct or matrixed), including coaching and performance management.
• Highly effective communicator with strong presentation, problem‑solving, and organizational skills, capable of independently engaging stakeholders and fostering effective relationships within multi-cultural and geographically diverse teams
• Advanced critical reasoning skills including the identification and resolution of a wide-range of complex problems
• Detailed-oriented with the ability to work independently and manage competing priorities, with a willingness to learn and adapt to new situations
• Competent in the application of standard business procedures (standard operating procedures (SOPs), International Conference on Harmonization (ICH), Global Regulations, Ethics, and Compliance).

Nice To Haves

• Advance degree
• Experience across multiple trial phases, therapeutic areas, and geographic regions
• Experience with risk-based monitoring models and clinical trial systems (e.g., CTMS, eTMF)

Responsibilities

• Provide oversight and direction for the activities of regional or global CRAs to ensure high-quality monitoring
• Assign CRAs to studies based on experience, workload, and study needs
• Conduct regular 1:1s to review study progress, address issues, and ensure monitoring activities meet expectations
• Facilitate CRA onboarding, training, and ongoing guidance
• Review and approve monitoring reports, trip reports, and follow-up letters as required
• Conduct co-monitoring and/or Sponsor oversight monitoring visits as required
• Ensure monitoring activities are conducted per protocol, the approved monitoring plan, ICH-GCP, SOPs, and applicable regulations
• Identify and proactively address monitoring risks, site performance issues, and compliance concerns
• Assist Study Manager with the creation and implementation of documents/tools related to study/site monitoring (e.g., Monitoring Plan, eligibility checklist, slot request forms)
• Partner with study teams to resolve site issues, deviations, and inspection readiness gaps
• Escalate quality, compliance, or resourcing risks appropriately
• Monitor CRA workload, utilization, and capacity planning
• Support study start-up, enrollment, and close-out activities from a monitoring perspective
• Collaborate with Clinical Operations leadership on resourcing strategies and forecasting
• Participate in audit and inspection readiness activities, including sponsor and regulatory inspections
• Work closely with Clinical Trial Managers, Project Managers, Data Management, and Safety teams
• Serve as a point of escalation for site-related and monitoring-related issues
• Provide input into monitoring strategies, including risk-based monitoring approaches
• Contribute to the development and refinement of monitoring SOPs and best practices
• Identify opportunities to improve monitoring efficiency, quality, and consistency
• Support implementation of new tools, systems, and training initiatives
• Up to 20% travel, depending on study and team needs

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager