临床数据管理员 II-III(武汉)
方恩医药科技发展有限公司WuhanUpdate time: July 10,2019
Job Description
Data Coordinator (Level 2) is a mid-level Data Coordinator. Key responsibilities and skills may include, but are not limited to:
- CRF/DCF tracking;
- Develop test scripts and execution logs for User Acceptance Testing (UAT);
- Database audit;
- Perform data review;
- Create and maintain Data Management Plan under the supervision of senior members;
- Create and maintain Data Validation Plan under the supervision of senior members;
- Create and maintain Data Entry Guidelines;
- Create Data Handling Plan under the supervision of senior members;
- Create Data Transfer Specification under the supervision of senior members;
- Perform CRF design and CRF review under the supervision of senior members;
- Develop database (DB) clinical trial data specifications under the supervision of senior members, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
- Perform SAE reconciliation;
- Perform external data reconciliation in collaboration with programmers; Other DM tasks as deemed appropriate by senior members.
Qualifications:
- Bachelor’s degree in clinical/pharmacy/biological/mathematical sciences or related field or nursing degree with 1 year clinical experience.
- Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
- Good understanding of clinical drug development process.
职能类别: 生物工程/生物制药 临床数据分析员
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上班地址:武汉平安金融科技大厦23楼2301
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