外资药厂急招Data Manager
科锐国际人力资源（北京）有限公司
- 公司规模：1000-5000人
- 公司行业：专业服务(咨询、人力资源、财会)
职位信息
- 发布日期：2014-07-14
- 工作地点：南京
- 招聘人数：1
- 工作经验：二年以上
- 学历要求：本科
- 职位月薪：面议
- 职位类别：临床数据分析员
职位描述
Job Description
Key responsibilities and skills may include, but are not limited to:
? Participate in the review of Clinical research documents (eg. Protocols, Case Report Forms);
? Develop Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements;
? Create and maintain Data Validation Plan;
? Create Data Entry Guidelines;
? Create Data Handling Plan;
? Create Data Transfer Specification;
? Develop and review Case Report Form (CRF), electronic and/or paper;
? Develop database (DB) clinical trial data specifications, including CRF annotation, edit rules/checks, query logic and data validations;
? Perform external data reconciliation in collaboration with programmers;
? Develop test scripts and execution logs for User Acceptance Testing (UAT);
? Perform training on study trials and create user guides;
? Perform database lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock;
? Coordinate the archiving of study databases and related documents;
? Database audit;
? Perform SAE reconciliation;
? Perform other activities as required;
? Provide mentorship to junior members;
? Working with project manager and cross functional team members to maintain project timeline and overall quality of deliveries.
Requirements
? Bachelor’s degree in clinical/pharmacy/biological/mathematical sciences or related field or nursing degree.
? At least 2 years data management and/or related work experience in a medical device or pharmaceutical industry/company is preferred.
? Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
? Working knowledge of Clinical database applications.
Key responsibilities and skills may include, but are not limited to:
? Participate in the review of Clinical research documents (eg. Protocols, Case Report Forms);
? Develop Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements;
? Create and maintain Data Validation Plan;
? Create Data Entry Guidelines;
? Create Data Handling Plan;
? Create Data Transfer Specification;
? Develop and review Case Report Form (CRF), electronic and/or paper;
? Develop database (DB) clinical trial data specifications, including CRF annotation, edit rules/checks, query logic and data validations;
? Perform external data reconciliation in collaboration with programmers;
? Develop test scripts and execution logs for User Acceptance Testing (UAT);
? Perform training on study trials and create user guides;
? Perform database lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock;
? Coordinate the archiving of study databases and related documents;
? Database audit;
? Perform SAE reconciliation;
? Perform other activities as required;
? Provide mentorship to junior members;
? Working with project manager and cross functional team members to maintain project timeline and overall quality of deliveries.
Requirements
? Bachelor’s degree in clinical/pharmacy/biological/mathematical sciences or related field or nursing degree.
? At least 2 years data management and/or related work experience in a medical device or pharmaceutical industry/company is preferred.
? Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
? Working knowledge of Clinical database applications.
公司介绍
作为亚洲领先的招聘整体解决方案提供商，科锐国际人力资源有限公司成立于1996年，目前在大中华地区拥有12个直属分公司及34个重点城市分支机构，超过900名专业招聘人员。科锐国际致力于在17个细分行业与领域中为客户提供最优质的服务，以满足客户在所有层次的招聘需求。科锐国际的客户80%来自世界知名集团，20%来自国内上市公司、快速成长性企业及非赢利组织。在过去的一年中，科锐国际成功为企业推荐的长期雇员及派遣雇员总数超过万人，中高级专业职位及管理职位超过4500个。