Global Clinical Trial Lead: Strategy & Delivery

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

Benefits offered by this job

401(k) eligibility

Paid time off

Job summary

Zai Lab is seeking a Senior Clinical Trial Manager in Cambridge, MA to lead global clinical trial operations from start-up to close-out, ensuring ICH-GCP compliance and cross-functional collaboration. This role is based in our Cambridge office and requires coordinating across time zones and vendors.

The position focuses on delivering study plans, managing budgets, and ensuring high-quality TMF, EDC, IxRS, and CTMS support.

Qualifications

• Undergraduate degree in a scientific or health-related discipline.
• Minimum 8 years relevant experience with 5 years in clinical study management or equivalent.
• Ability to work across several time zones.

Responsibilities

• Lead and coordinate a cross-functional study team to ensure the clinical trial progresses as planned.
• Oversee overall operational strategy and delivery (site selection/start-up, contracts, recruitment, etc.) managing timeline, budget, and quality.
• Develop and finalize cross-functional activities to ensure delivery of critical documents (ICFs, protocols, budgets, TMF, etc.).
• Drafts and implements study plans including vendor oversight, risk, quality, safety, communication, 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; propose resolutions.
• Drive vendor selection via RFP and oversee outsourced activities to CROs/vendors.
• Lead Investigator Meeting preparation and execution with cross-functional support.
• Stay current on therapeutic area knowledge and clinical research best practices.
• Ensure study adherence to ICH/GCP and SOPs.

Skills

Cross-functional collaboration

Vendor management

Project leadership

Regulatory knowledge (ICH/GCP)

Communication skills

Time zone coordination

Education

Undergraduate degree in science/health

Job description

Zai Lab is seeking a Senior Clinical Trial Manager in Cambridge, MA to lead global clinical trial operations from start-up to close-out, ensuring ICH-GCP compliance and cross-functional collaboration. This role is based in our Cambridge office and requires coordinating across time zones and vendors.

The position focuses on delivering study plans, managing budgets, and ensuring high-quality TMF, EDC, IxRS, and CTMS support.