- 招聘类型:社招
- 工作性质:全职
- 直属部门:Clinical Operations
职位描述
Major Responsibilities
1.Assists COM/ACOM/SSU Lead to develop and coordinate to manage the study budget, accruals and actual cost, coordinate with CTA & CRA ensures study payments are paid on time
2.Assists COM/ACOM/SSU Lead to develop study documents and other materials
3.Coordinates vendor selection (CRO, translation, printing, travel agency, etc.) and management
4.Supports TMF related work both paper and electronic Trial Master Files (eTMF) and study SharePoint, conducts eTMF QC if needed
5.Supports PFDA document filing, CDE posting, CHGRAO submission, and ensures required documents are submitted to relevant functions/websites
6.Assists COM/ACOM/SSU Lead to organize study team meetings, including meeting room booking and setup, meeting minutes taken is required; Provides enough logistic support for investigator meetings
7.Coordinates with Clinical Supply Chain regarding drug forecasting and supply
8.Coordinates with various system account apply and management
9.Prepares and maintains various study tracker/metrics
任职条件
Qualification
1.Bachelor’s level degree or above in life sciences, English and management
2.Fluent in English (listening, writing)
3.Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
4.3 years (PMA), 5 years or above (Sr. PMA) of CTA/PMA or clinical trial experience in the Pharmaceutical or CRO industry
5.Excellent communication and interpersonal skills
职位要求
- 学历要求:无
- 工作经验:无
- 外语要求:不需要
公司福利
- 五险一金
- 晋升空间
- 法定节假日
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