Job Summary

• Manage and lead the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Responsible for oversight and guidance to clinical study team members in completing deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned studies.
• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; support development of data review plans, review of statistical analysis plans and participate in data reviews and manage data findings.

Matching Summary

Skills & Requirements

Key Requirements

• 5 years clinical trial experience (BA/BS)
• 3 years clinical trial experience (Advanced degree)
• Strong knowledge of ICH/GCP guidelines
• Strong knowledge of protocol and clinical drug development processes
• Proven project management skills
• Global experience (China preferred)
• Open to working PST time

Work Rights