clinical data management specialist
上海康德保瑞医学临床研究有限公司
- 公司规模：150-500人
- 公司性质：合资(欧美)
- 公司行业：医疗/护理/卫生
职位信息
- 发布日期：2015-03-26
- 工作地点：北京-朝阳区
- 招聘人数：若干
- 工作经验：2年
- 学历要求：本科
- 语言要求：英语良好
- 职位月薪：面议
- 职位类别：临床数据分析员
职位描述
Clinical Data Coordinator – Role Description
Position Purpose:
The Clinical Data Coordinator supports the operational aspects of preparing submission data, and required documentation, for regulatory authorities and the greater clinical research community.
Major Tasks of Position:
Operational Data Management:
? Supports study data management and data cleaning processes on an ongoing basis, applying study specific documents and conventions
? Identifies and issues queries, incorporates query replies, tracks query status and applies permissible clarifications using the EDC and related systems where applicable
? This includes but is not limited to:
？ Identifying, Issuing, Closing queries
？ Tracking
？ SAE reconciliation
？ Reconciliation of external vendor data
？ Participation in User Acceptance Testing
？ Data Entry, if required
Ensuring Compliance:
? Performs duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards
? Applies and contributes to the development of adequate Data Management Best Practices within scope of own responsibilities and task assignments
Position Purpose:
The Clinical Data Coordinator supports the operational aspects of preparing submission data, and required documentation, for regulatory authorities and the greater clinical research community.
Major Tasks of Position:
Operational Data Management:
? Supports study data management and data cleaning processes on an ongoing basis, applying study specific documents and conventions
? Identifies and issues queries, incorporates query replies, tracks query status and applies permissible clarifications using the EDC and related systems where applicable
? This includes but is not limited to:
？ Identifying, Issuing, Closing queries
？ Tracking
？ SAE reconciliation
？ Reconciliation of external vendor data
？ Participation in User Acceptance Testing
？ Data Entry, if required
Ensuring Compliance:
? Performs duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards
? Applies and contributes to the development of adequate Data Management Best Practices within scope of own responsibilities and task assignments
公司介绍
WuXi PRA Clinical Research (Shanghai) Co., Ltd. offers comprehensive Phase I-IV clinical trial services in Mainland China, Hong Kong and the Asia region. With 5 offices and staff based in 17 cities across China, WuXiPRA’s locally based project teams operate with the support of PRA’s global resources, clinical research expertise, global technologies and SOPs. This centralized operational approach promotes higher quality and outstanding client service. WuXiPRA has invested significantly in staff focused on CFDA regulatory expertise, project management and clinical informatics resources, as well as other support services, including RPS embedded strategic outsourcing.
上海康德保瑞医学临床研究有限公司在中国内地、香港及亚洲地区提供全方位的I-IV期临床试验服务。 康德保瑞在中国有5个办公室，员工分布在17个城市，其团队拥有保瑞医药丰富的全球资源和临床研究专业知识以及全球化的技术和标准操作规程支持。这些有助于全球性、区域性以及本土的临床试验运作达到更高的质量。康德保瑞在人员方面投入巨大，主要集中在CFDA注册专业知识、项目管理、临床信息资源以及包括战略外包服务的其它支持服务方面。
上海康德保瑞医学临床研究有限公司在中国内地、香港及亚洲地区提供全方位的I-IV期临床试验服务。 康德保瑞在中国有5个办公室，员工分布在17个城市，其团队拥有保瑞医药丰富的全球资源和临床研究专业知识以及全球化的技术和标准操作规程支持。这些有助于全球性、区域性以及本土的临床试验运作达到更高的质量。康德保瑞在人员方面投入巨大，主要集中在CFDA注册专业知识、项目管理、临床信息资源以及包括战略外包服务的其它支持服务方面。