• 招聘类型：社招
• 工作性质：全职

职位描述

• Deciphers IRT study specific requirements to ensure proper risk mitigation while developing test plans.
• Authors test scripts to ensure documented evidence is generated to prove that the system performs as intended.
• Leads UAT by defining, developing and implementing practices and procedures for complete end user test plans.
• Provides training and support to team members to ensure successful execution of test scripts.
• Participates in the tracking and management of open issues and raises ongoing issues.
• Responsible for overall success of user acceptance testing, including results verification and release approvals.
• Ensures all user acceptance tests are documented according to standards.
• Understands industry issues faced in sponsor driven IRT UAT efforts and supports several moderately complex business processes.
• Gathers information about current work processes and information flows and documents existing business process to define new enhancements to gain better efficiency in the testing process.
• Has strong knowledge of testing processes, methodologies and tools
• Communicates effectively via email and conference calls as needed.
• Provide guidance to cross functional teams and management on IRT best practices and trends.
• Ensure systems and documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, Annex 13 as well as in accordance BeiGene SOPs and processes.
• Additional responsibilities as required.

任职条件

• Demonstrates knowledge of global clinical trials and the drug development process.
• Understands comprehensive global pharmaceutical regulatory requirements (e.g. ICH/GDP, GCP, 21 CFR Part 11, and Annex 13).
• Experience in development IRT system plans and specifications.
• Working knowledge of EDC.
• Ability to work effectively in cross-functional and multi-cultural teams.
• Bachelor or Master Degree in Computer Science, Business Administration, Operations Management, or similar education required. 5+ years progressive experience in IRT validation.

职位要求

• 学历要求：本科
• 工作经验：无
• 外语要求：English

公司福利

• 五险一金 
• 晋升空间 
• 法定节假日