临床数据监察员Clinical Data Supervisor
白鹭医药技术(上海)有限公司
- 公司规模:少于50人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2017-02-27
- 工作地点:上海-浦东新区
- 招聘人数:若干人
- 学历要求:本科
- 语言要求:英语 精通
- 职位月薪:6000-9000/月
- 职位类别:临床数据分析员
职位描述
职位描述:
The Clinical Data Supervisor will:
Analyze the enrollment status and alert the clinical program manager if unusual activities or absences of activities are detected
Verify accuracy of case report forms against study protocol
Monitor clinical data entry time and completeness based on scheduled clinical visits during a trial
Review laboratory data periodically and identify any laboratory values that are significantly outside the normal range.
Perform initial assessment to determine whether the abnormal values may result from a laboratory error or may be clinically significant and alert appropriate clinical project team members accordingly.
Review inclusion and exclusion criteria, medical history, demographics and or other baseline characteristics of study subjects to alert team to any eligibility violation
Review adverse event data and concomitant medication use to detect unusual or absent activities. Identify outliers in safety data pattern.
Review and revise adverse event and medication coding for consistency and accuracy
Perform periodic pharmacovigilance analysis to detect safety signals
Generate graphs and reports using spreadsheet and database tools
QUALIFICATIONS:
Bachelor of Medicine, or higher
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
Proficient in English reading and verbal communication
Proficient in Microsoft Excel and data table manipulations
Familiar with statistical methods for data analysis
Familiar with medical terms and laboratory testing principles
Familiar with database structure and electronic data capture is a plus
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The Clinical Data Supervisor will:
Analyze the enrollment status and alert the clinical program manager if unusual activities or absences of activities are detected
Verify accuracy of case report forms against study protocol
Monitor clinical data entry time and completeness based on scheduled clinical visits during a trial
Review laboratory data periodically and identify any laboratory values that are significantly outside the normal range.
Perform initial assessment to determine whether the abnormal values may result from a laboratory error or may be clinically significant and alert appropriate clinical project team members accordingly.
Review inclusion and exclusion criteria, medical history, demographics and or other baseline characteristics of study subjects to alert team to any eligibility violation
Review adverse event data and concomitant medication use to detect unusual or absent activities. Identify outliers in safety data pattern.
Review and revise adverse event and medication coding for consistency and accuracy
Perform periodic pharmacovigilance analysis to detect safety signals
Generate graphs and reports using spreadsheet and database tools
QUALIFICATIONS:
Bachelor of Medicine, or higher
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
Proficient in English reading and verbal communication
Proficient in Microsoft Excel and data table manipulations
Familiar with statistical methods for data analysis
Familiar with medical terms and laboratory testing principles
Familiar with database structure and electronic data capture is a plus
职能类别: 临床数据分析员
关键字: 临床数据
公司介绍
白鹭医药技术(上海)有限公司由哈佛大学知名教授/药物发明人创办经营,自2003年成立至今已12年有余,是国内较少的真正专注于新药研发并以国际市场为目标市场的医药生物技术公司。目前已有我公司参与研发项目在北美和欧洲进入III期临床研究。我公司参与研究的项目均属国际前沿,强烈需求对研发工作有浓厚兴趣的生物医药精英人才,到这里您将成为国际一流药物研发团队的一员!公司坐落于著名的上海张江药谷,科研条件和工作环境颇佳,科研人员收入具有市场竞争力,欢迎对科研工作有热情有天赋的广大生物医药人员踊跃投递简历!
联系方式
- 公司地址:上班地址:张江药谷哈雷路1118号4楼