Clinical Trial Manager

$135,000 - $165,000/Yr

Zai Lab - South San Francisco, CA

Full-time - Senior

South San Francisco, CA

1,001-5,000 employees

Professional, Scientific, and Technical Services

About the position

The Clinical Trial Manager at Zai Lab will lead and coordinate the operational delivery and execution of clinical trials from start-up to close-out, ensuring compliance with ICH-GCP and local regulations. This role involves collaboration with cross-functional teams to meet quality, budget, and timing deliverables, and may oversee multiple trials simultaneously.

Responsibilities

• Lead and coordinate a cross-functional study team to ensure clinical trials progress as planned.
• Accountable for the overall operational delivery of assigned clinical trials, 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 resolutions.
• Provide input to the study budget and manage assigned vendor budgets, communicating variances and presenting action plans for resolution.
• 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 the Investigator Meeting preparation and execution with support from cross-functional team members.
• 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 of relevant experience, with 3 years of clinical experience in the pharmaceutical industry.
• Demonstrated ability in clinical study management processes and clinical/drug development.
• Highly effective verbal and written communication skills.
• 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.

Nice-to-haves

• One year of study management experience.

Benefits

• Restricted Stock Units (RSU)
• Paid time off
• Parental leave