Job Description

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 Cambridge, MA office.

CRA Management & Oversight

• 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

Study Execution & Quality

• 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
• Operational & Resource Management
• 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

Cross-Functional Collaboration

• 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

Process Improvement

• 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

Qualifications

_ Required_

• 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.

_ Preferred_

• 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)
• 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).

Additional Information

The pay range for this position at commencement of employment is expected to be between $145K and $160K/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 Lab, 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, 59% of our employees are women and 53% of our management positions are held by women. We are committed to the health of patients and our planet. That’s 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.

Zai Lab is committed to protecting the privacy and security of the information we collect and to being transparent about the purposes for which we use your information. We have aPrivacy Notice which sets forth our policies and practices for handling the information we collect and use in the employment context. Privacy Notice available upon request.