Clinical Operations Manager Office Based Cambridge 3Xwk
Zai Lab (US) LLC, Cambridge, MA, United States
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
Advanced 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
Detail-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 (SOPs, ICH, Global Regulations, Ethics, and Compliance)
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 other benefits such as 401(k) eligibility and various paid time off benefits, including vacation, sick time, and parental leave.
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 disability.
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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
Advanced 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
Detail-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 (SOPs, ICH, Global Regulations, Ethics, and Compliance)
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 other benefits such as 401(k) eligibility and various paid time off benefits, including vacation, sick time, and parental leave.
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 disability.
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