Global Clinical Trial Operations Leader

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

Job summary

Zai Lab Limited is seeking a Senior Clinical Trial Manager to lead and coordinate the operational strategy, risk management, and execution of global clinical trials in accordance with ICH-GCP and local regulations. The role is based in our Cambridge, MA office.

You will collaborate with cross-functional teams, manage budgets and timelines, and oversee vendor relationships to ensure quality and timely trial delivery across multiple sites and countries.

Qualifications

• Undergraduate degree in a scientific or health-related discipline.
• Minimum of 8 years relevant experience, including 5 years clinical experience in the pharmaceutical industry, with at least 3 years in study management.
• Ability to work across several time zones.

Responsibilities

• Lead and coordinate a cross-functional study team to ensure the clinical trial progresses as planned.
• Accountable for overall operational strategy and delivery (country/site start-up, site contracts, patient recruitment and retention) of assigned trials.
• Develop and finalize cross-functional documents and plans (ICFs, protocols, TMF, EDC, IxRS, CTMS).
• Draft and implement study plans including vendor oversight, risk, quality, safety, communication, and trial monitoring.

Skills

Study management

Vendor management

Budget oversight

Education

Bachelor's degree in scientific/health-related discipline

Tools

EDC

IxRS

CTMS

Job description

Zai Lab Limited is seeking a Senior Clinical Trial Manager to lead and coordinate the operational strategy, risk management, and execution of global clinical trials in accordance with ICH-GCP and local regulations. The role is based in our Cambridge, MA office.

You will collaborate with cross-functional teams, manage budgets and timelines, and oversee vendor relationships to ensure quality and timely trial delivery across multiple sites and countries.