Global Clinical Trial Lead Cross-Functional Strategy

Zai Lab; Cambridge (MA); On-site; USD 164,000 - 214,000; Full time

Benefits offered by this job

401(k) plan

Medical benefits

Paid time off

Job summary

Zai Lab is seeking a Senior Clinical Trial Manager for our Cambridge, MA office. You will lead global trial operations from start-up to close-out, coordinating cross-functional teams to meet quality, budget, and timing requirements.

The role requires 8+ years in clinical operations (5 in study management), strong ICH-GCP knowledge, and excellent communication across time zones. You will drive vendor selection, TMF, and cross-functional collaboration to ensure study success.

Qualifications

• Minimum of 8 years relevant experience with at least 5 years in clinical operations and 3 years in study management or equivalent.
• Ability to work across several time zones and collaborate with global teams.
• Strong understanding of ICH-GCP and clinical trial processes.

Responsibilities

• Lead and coordinate a cross-functional study team to ensure the clinical trial progresses as planned.
• Oversee overall operational strategy and delivery including site activation, budget, and quality requirements.
• Develop and finalize cross-functional study documents (ICFs, protocols, budgets, TMF).
• Draft and implement study plans covering vendor oversight, risk, quality, safety, and monitoring.
• Ensure TMF creation and QC completion; support EDC, IxRS, and CTMS data maintenance.
• Track budgets, timelines, milestones, and critical activities; propose resolutions to variances.
• Manage study budgets and vendor budgets; present action plans for variances.
• Oversee vendor selection and CRO oversight; participate in RFP processes.
• Lead Investigator Meeting preparation and execution with cross-functional support.
• Maintain current knowledge of therapeutic areas and clinical research best practices.
• Ensure study adherence to ICH/GCP and company SOPs.

Skills

Cross-functional collaboration

Effective communication

Vendor management

Project leadership

Education

Undergraduate degree in science/health

Job description

Zai Lab is seeking a Senior Clinical Trial Manager for our Cambridge, MA office. You will lead global trial operations from start-up to close-out, coordinating cross-functional teams to meet quality, budget, and timing requirements.

The role requires 8+ years in clinical operations (5 in study management), strong ICH-GCP knowledge, and excellent communication across time zones. You will drive vendor selection, TMF, and cross-functional collaboration to ensure study success.