Clinical Operations Manager (Office Based - Cambridge 3X/wk) at Zai Laboratory US

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Jul, 26

Salary

160000.0

Posted On

18 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical operations, People management, Clinical research associate oversight, ICH-GCP compliance, Monitoring plan development, Risk-based monitoring, Clinical trial management, Performance management, Regulatory compliance, Data integrity, Site monitoring, Co-monitoring, Audit readiness, Cross-functional collaboration, Problem-solving, Communication

Industry

Biotechnology Research

Description

Company Description Zai Lab is a patient-focused, innovative, commercial-stage, global biopharmaceutical company based in China and the United States. We are dedicated to discovering, developing, and commercializing best-in-class and first-in-class therapies that address medical conditions with significant unmet needs in oncology, immunology, neuroscience, and infectious disease. Guided by innovation and driven by purpose, our mission is to leverage our expertise and resources to make a lasting, positive impact on human health worldwide. Zai Lab’s global team of 2,100 talented professionals includes industry leaders and professionals dedicated to advancing novel therapies to patients. With headquarters in Cambridge, Massachusetts, and Shanghai, and teams in the U.S., China and Europe, we collaborate across time zones to deliver meaningful impact where it’s needed most. Founded in 2014 by Dr. Samantha Du, Zai Lab was purpose-built to become a leading global biopharma, combining scientific innovation, operational scale, and strong execution. Our global pipeline features ZL-1310, a DLL3 antibody-drug conjugate (ADC) with best-in-class and first-in-class potential in small cell lung cancer, now in clinical trials. At the same time, our R&D team is progressing several other global programs into the clinic, including ZL-1503, a bispecific IL-13/IL-31 antibody for atopic dermatitis, and ZL-6201, an LRRC15 ADC for solid tumors. In China, we’ve earned a reputation as a partner of choice for leading global biopharmaceutical companies, leveraging our proven commercial infrastructure and clinical trial capabilities to accelerate market access to our innovative products. Due to its large population, China is the second largest pharmaceutical market in the world. Our unique business model combines in-licensed assets with strategic partnerships, leveraging our in-house research capabilities to build a regional portfolio of late-stage, potential best-in-class and first-in-class therapies. Today, with eight products on the market in China, we are delivering meaningful impact for patients and building opportunities for talented professionals to shape the future of medicine. Zai Lab is publicly traded with dual-primary listings on both the Nasdaq Stock Market and the Hong Kong Stock Exchange, underscoring our commitment to transparency, global reach, and long-term growth. 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 a Privacy 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.

Responsibilities

The Clinical Operations Manager oversees Clinical Research Associates to ensure high-quality execution of clinical trials in compliance with regulatory standards. This role manages monitoring activities, site performance, and cross-functional collaboration to support study timelines and patient safety.