碧桂园 - 运营
刷新日期： 2019-11-18 截止日期： 2019-12-01
1. Primary Purpose of Job (Job Summary) 主要工作目标（岗位简介）
（1）Scanning Hub Support
- Review and scan the clinical trial related documents with high quality according to the scanning hub requirements and upload to required system within required timeline.
- Maintain local scanning hub public mailbox in a timely manner including review, reply and archive important communication.
- Maintain the local scanning status tracker daily to ensure all documents could be scanned and uploaded within required timeline.
- Answer and resolve any query from global scanning hub responsible, CDC.
- Provide support and input to improve the local process of scanning if needed.
（2）Clinical Trial Document Archiving
- Be familiar with the content of clinical trial master file and investigator site file based on the requirements of ICH GCP, China regulation and Roche SOPs, guidance.
- Review the closed clinical trial documents, support archiving responsible to arrange and archive them according to related SOP requirements.
（3）Business Support to Department
- Understand ICH GCP, China GCP and related regulation on clinical trials, especially on Ethic Committee (EC) requirements for study initiation.
- Support SSUS to prepare the essential EC submission package according to required timeline.
（4）General Office Duties
- Provide general office support to PDG CCO department staff (including but not limited to photocopying, distributing mail/faxes, scanning, faxing,).
- Organize courier services for documents/ goods pick-up.
- Administrative supports on the activities assigned by line manager
2. Qualification and Experience 能力与经验
- Bachelor degree preferred (4th year student)
- Major in Pharmacy or medical related
- Good ownership and focus on details
- Logical and efficient with highly compliance
- Be willing to learn, think and practice
（3）Job Required Competencies岗位所需胜任力
- Good Computer skill for Window 7, Microsoft 2010 (PPT, Excel, Word)
- Strong communication skills
- Fluent English written and oral capability