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About the Role

The Clinical Trial Manager will lead, manage, and coordinate the operational delivery, risk management, and overall execution of clinical trials from study start-up to close out at a regional or global level. This role collaborates with cross-functional stakeholders to ensure deliverables are met in terms of quality, compliance, budget, and timing, potentially supporting one or several trials.

Responsibilities

• Lead and coordinate a cross-functional study team (regional or global) to ensure the clinical trial progresses as planned.
• Accountable for the overall operational delivery of assigned clinical trials or regions, ensuring study-level deliverables are met according to timeline, budget, and quality requirements.
• Participate in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents.
• Draft and implement study plans including vendor oversight, risk, quality, safety, communication, trial monitoring, and TMF.
• Ensure TMF creation and QC completion.
• Support EDC, IxRS, and CTMS systems and data maintenance.
• Track budget, timelines, milestones, and critical study activities, identifying issues and proposing potential resolutions.
• Provide input to the study budget and manage assigned vendor budget(s), communicating variances and presenting action plans.
• Participate in the selection of vendors on a global scale.
• Oversee delegated outsourced activities to ensure CRO and vendor delivery against the contracted scope of work.
• Lead Investigator Meeting preparation and execution.
• Stay current on relevant therapeutic area knowledge and clinical research best practices.
• Ensure study adherence to ICH/GCP and company SOPs.

Requirements

• Undergraduate degree in a scientific or health-related discipline.
• 5 years relevant experience, with 3 years in clinical experience in the pharmaceutical industry.
• One year of study management experience.
• Demonstrated ability in clinical study management processes and clinical/drug development.
• Highly effective verbal and written communication skills; ability to independently communicate with teams and stakeholders.
• Experience with effective vendor management.
• Strong customer focus with investigators, functional peers, vendors, etc.
• Excellent planning and organizational skills.
• Working knowledge of international regulatory and ICH Good Clinical Practice guidelines.
• Ability to build trusting and collaborative relationships globally.
• Willingness to travel domestically and internationally and work across cultures.

Skills

• Clinical trial management
• Operational delivery
• Risk management
• ICH-GCP compliance
• Cross-functional collaboration
• Budget management
• Vendor oversight
• Study planning
• TMF management
• EDC, IxRS, CTMS systems
• Therapeutic area knowledge
• Communication skills
• Planning and organizational skills
• International regulatory guidelines

Location

• South San Francisco, CA

Work Type

• Full-time

Experience Level

• 5 years relevant experience
• 3 years clinical experience
• 1 year study management experience

Education Level

• Undergraduate degree in a scientific or health-related discipline

Salary/Compensations

• $145K - $170K/year

Benefits

• Full range of medical, financial, and/or other benefits
• 401(k) eligibility
• Various paid time off benefits (vacation, sick time, parental leave)
• Sign-on bonus
• Restricted stock units
• Discretionary awards

About the Company

• Zai Lab is a patient-focused, innovative, commercial-stage, global biopharmaceutical company based in China and the United States.
• Dedicated to discovering, developing, and commercializing best-in-class and first-in-class therapies in oncology, immunology, neuroscience, and infectious disease.
• Mission: Leverage expertise and resources to make a lasting, positive impact on human health worldwide.
• Global team of 2,100 professionals with headquarters in Cambridge, MA, and Shanghai, and teams in the U.S., China, and Europe.
• Founded in 2014 by Dr. Samantha Du.
• Publicly traded with dual-primary listings on Nasdaq and Hong Kong Stock Exchange.
• Proud of gender diversity and promotion of women in biotech, achieving gender pay equity.
• Committed to environmental protection, social responsibility, and corporate governance ('Trust for Life').

Equal Opportunity

• 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.