Senior Project Manager

• Jun 2022 - Present

Project Manager

• Feb 2021 - Jun 2022

•Manage more than 20 oncology projects in Hong Kong, Taiwan and Singapore, within scope and within budget.•Preparing initial IRB/EC and Regulatory submission packages.•Sites training: lab manual instruction, test requisition documents preparation, and sample logistics.•Site monitoring and maintaining contracts; performing troubleshooting to ensure project progress on the timeline.• Provide periodical report to sponsor or PI for schedule controlling and risk management.•Coordinate internal resources and third parties/vendors for the flawless execution of multiple projects.•Develop the related documents and participate in external audits. Show less

Clinical Trial Specialist

• Nov 2019 - Feb 2021

• Preparing initial IRB/EC and Regulatory submission packages. • Responsible for IRB/EC and Regulatory review comment reply. • Performing study tracking to ensure that all study files and documents are accurate, current and complete. • Performing essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and in compliance with applicable local regulatory requirements, ICH/GCP guidelines and SOPs. • Tracking the changes against Form 1572 requirements during the clinical trial submission stage (including obtaining medical licenses and CVs related to these changes). • Preparing SRP (Site Regulatory Packages) and submitting for PM review before SIV. • Assisting CRAs in the preparation, submission, and archiving of IRB/EC, and Regulatory amendment of submission package. • Performing other duties as assigned. Show less

Project Manager

• Jun 2018 - Oct 2019

• Preparing initial IRB/EC and Regulatory submission packages. • Responsible for IRB/EC and Regulatory review comment reply. • Performing study tracking to ensure that all study files and documents are accurate, current and complete. • Performing essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and in compliance with applicable local regulatory requirements, ICH/GCP guidelines and SOPs. • Tracking the changes against Form 1572 requirements during the clinical trial submission stage (including obtaining medical licenses and CVs related to these changes). • Preparing SRP (Site Regulatory Packages) and submitting for PM review before SIV. • Assisting CRAs in the preparation, submission, and archiving of IRB/EC, and Regulatory amendment of submission package. • Performing other duties as assigned. Show less

Technical Assistant

• Jul 2013 - Sep 2013

--Learn techniques of molecular and genomic sequencing. --Accomplish sequencing cases of microbiology identification. --Learn techniques of molecular and genomic sequencing. --Accomplish sequencing cases of microbiology identification.