倍思大生技股份有限公司

1.Planning, coordinating, and conducting audits : Clinical trial audits、Supplier audits、Audit reports 2.Risk and quality management : Identify and follow up on corrective and preventive actions for quality-related issues 3.Independent activities : Assisting in the organization and management of independent committees to ensure their operations comply with relevant regulations Randomization code quality control 4.Training : Planning and maintaining the training system (training programs, training materials, and certificate management)、Training record analysis 5.Document management : SOPs, policies, and manuals: developing, maintaining, and updating company、 SOPs, policies, and manuals to ensure they align with the latest regulatory、 requirements and industry standards、Archives: managing the clinical trial-related documents that are archived in the archiving room 6.Other assigned QA tasks

1.Review, develop, and maintain regulatory documents and safety databases 2.Conduct PV: receiving, processing, submitting, maintaining safety cases/regulatory data, and medical coding 3.Establish and facilitate communication with study sites, the EC/IRB, and health authorities 4.As appropriate, assist Bestat and relevant parties in facilitating medical monitoring and regulatory processes, management, and policies

1. Develop and maintain regulatory documents 2. Conduct PV, which includes receiving, processing, submitting, and maintaining safety and regulatory data/reports 3. Engage in active communication with study sites, the respective EC/IRB, and health authorities 4. As appropriate, assist Bestat and relevant parties in better understanding regulatory processes and policies 5. Address regulatory-related issues and considerations raised by the sponsor, investigator, study sites, and health authorities