Data Manager临床数据分析员
丘以思（上海）医药信息咨询有限公司
- 公司规模：50-150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：2017-02-03
- 工作地点：北京-朝阳区
- 招聘人数：10人
- 工作经验：2年经验
- 语言要求：英语
- 职位月薪：8000-15000/年
- 职位类别：临床数据分析员
职位描述
职位描述：
Position Summary
The Sr. Study Data Manager (Sr SDM) is responsible for developing and implementing Data-Management planning for specific studies, for ensuring that the activities are completed according to agreed standards and timelines and for coordinating ongoing data management to support the flawless conduct of a clinical trial, by acting as representative in the study team.
Key Word: 临床数据员/ 临床数据分析
岗位职责：
Duties and Responsibilities
1. Primary contact between Trial Operation and clinical study teams. Liaises directly with internal customers (Clinical, Biostatistics, Quality Assurance, Regulatory Affairs) and external customers (affiliates, CROs, clinical research units) to cover all aspects of data management for assigned studies. Negotiates responsibilities and timelines. Ensures departmental companion groups (i.e., Coding, TIM, Reporting Factory) are consulted appropriately on study decisions. Implements and oversees processes and coordinates activities in conjunction with the study team and Team Leader. Proposes solutions for data management issues that arise during the conduct of a study.
2. In charge of the development of CRFs, Data Management Plan, Data Validation Plan, Data Review Report as per company standards. Assures that data management standards are followed for the studies in charge.
3. Coordinates DM study teams (Clinical Data Coordinators, contractors) assigned to support studies.
4. Continually evaluates DM processes and applications for improvements. Participates in working groups to develop and implement new applications and procedures. Maintains knowledge of current regulations and technologies related to the data management function.
5. Participates in the implementation of department initiatives.
6. Assume the mentor role for junior staff and oversee the quality of data management activities for designated mentee.
任职要求：
Knowledge and Skill Requirements
Knowledge &Skills:
Solid Clinical Data Management System experience (e.g., Clintrial, Oracle Clinical) and understanding of database/programming concepts. Expert in the use of Data Management applications and database/file structures; able to identify discrepencies by using query langurages, such as SQL; able to acquire and apply new technical skills. Knowledge of industry standards and practices. Understands the clinical development process. Communicates effectively with study teams and departmental associates. Establishes rapport and collaborates with others both inside and outside the company; builds constructive and effective relationships; demonstrates flexibility through effective negotiations, can be direct yet diplomatic. Anticipates problems, issues, and delays, and proactively works to minimize the impact; follows through on all tasks and ensures high quality results. Consistently meets deadlines according to accepted levels of quality, paying attention to details. Learns quickly when facing new problems; uses rigorous, objective logic and methods to solve difficult problems with effective solutions; follows implementation plans through to completion. Sets clear assignments as well as clear objectives and measures; monitors process, progress and results. Oral and written English communication skills.
Education and experience required:
Bachelor degree or above, preferably in a life science or mathematics-related area (e.g., computer sciencecs) and equivalent experience (at least 4 years) in clinical data management.
工作地址
北京
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Position Summary
The Sr. Study Data Manager (Sr SDM) is responsible for developing and implementing Data-Management planning for specific studies, for ensuring that the activities are completed according to agreed standards and timelines and for coordinating ongoing data management to support the flawless conduct of a clinical trial, by acting as representative in the study team.
Key Word: 临床数据员/ 临床数据分析
岗位职责：
Duties and Responsibilities
1. Primary contact between Trial Operation and clinical study teams. Liaises directly with internal customers (Clinical, Biostatistics, Quality Assurance, Regulatory Affairs) and external customers (affiliates, CROs, clinical research units) to cover all aspects of data management for assigned studies. Negotiates responsibilities and timelines. Ensures departmental companion groups (i.e., Coding, TIM, Reporting Factory) are consulted appropriately on study decisions. Implements and oversees processes and coordinates activities in conjunction with the study team and Team Leader. Proposes solutions for data management issues that arise during the conduct of a study.
2. In charge of the development of CRFs, Data Management Plan, Data Validation Plan, Data Review Report as per company standards. Assures that data management standards are followed for the studies in charge.
3. Coordinates DM study teams (Clinical Data Coordinators, contractors) assigned to support studies.
4. Continually evaluates DM processes and applications for improvements. Participates in working groups to develop and implement new applications and procedures. Maintains knowledge of current regulations and technologies related to the data management function.
5. Participates in the implementation of department initiatives.
6. Assume the mentor role for junior staff and oversee the quality of data management activities for designated mentee.
任职要求：
Knowledge and Skill Requirements
Knowledge &Skills:
Solid Clinical Data Management System experience (e.g., Clintrial, Oracle Clinical) and understanding of database/programming concepts. Expert in the use of Data Management applications and database/file structures; able to identify discrepencies by using query langurages, such as SQL; able to acquire and apply new technical skills. Knowledge of industry standards and practices. Understands the clinical development process. Communicates effectively with study teams and departmental associates. Establishes rapport and collaborates with others both inside and outside the company; builds constructive and effective relationships; demonstrates flexibility through effective negotiations, can be direct yet diplomatic. Anticipates problems, issues, and delays, and proactively works to minimize the impact; follows through on all tasks and ensures high quality results. Consistently meets deadlines according to accepted levels of quality, paying attention to details. Learns quickly when facing new problems; uses rigorous, objective logic and methods to solve difficult problems with effective solutions; follows implementation plans through to completion. Sets clear assignments as well as clear objectives and measures; monitors process, progress and results. Oral and written English communication skills.
Education and experience required:
Bachelor degree or above, preferably in a life science or mathematics-related area (e.g., computer sciencecs) and equivalent experience (at least 4 years) in clinical data management.
工作地址
北京
职能类别： 临床数据分析员
关键字： 临床数据员 临床数据分析 Clinical, data, manager, DM
公司介绍
Clinipace Clinical Research，一个基于科技的全球性全方位服务的数字化合同研究组织（dCRO）。我们开创性的开发了依靠技术创新的CRO服务模式，以满足风险投资支持的，中型的战略性制药，生物技术公司以及医疗器械公司的研发需求。
借助于我们专有的TEMPO?电子化临床试验平台，我们的专家团队用他们丰富的治疗领域知识和见解来帮助生命科学公司制定和执行注册策略，临床开发和上市后研究，以确保药物和医疗器械开发计划的成功。
Clinipace的***目标就是通过开拓创新的技术继续坚定不移地致力于客户的成功，以最具性价比的全球性解决方案服务客户，提供高透明度，灵活和高质量的服务。
我们已经开展了超过1500个全球性的临床研究，完成了超过300个注册和开发策略制定项目。治疗领域涵盖如心血管和代谢，中枢神经系统，皮肤，消化，免疫，感染，***，肿瘤，呼吸，风湿和疫苗（和其他细胞和组织疗法）。
Clinipace刚刚庆祝了他们的10周年。如今，Clinipace其总部设在美国北卡罗莱纳州的Research Triangle Park，为横跨4大洲的27个国家提供服务。
因为对更高的数据准确度，经济高效的解决方案和更低的研发成本的需求在不断的增加，Clinipace还在持续的在全球扩张。
最后, Clinipace以正直透明、追求卓越绩效的企业文化邀请您的加入.
公司主页：*************************
最后, 丘以思以正直透明、追求卓越绩效的企业文化邀请您的加入.
应聘邮箱：kding@clinipace.com
借助于我们专有的TEMPO?电子化临床试验平台，我们的专家团队用他们丰富的治疗领域知识和见解来帮助生命科学公司制定和执行注册策略，临床开发和上市后研究，以确保药物和医疗器械开发计划的成功。
Clinipace的***目标就是通过开拓创新的技术继续坚定不移地致力于客户的成功，以最具性价比的全球性解决方案服务客户，提供高透明度，灵活和高质量的服务。
我们已经开展了超过1500个全球性的临床研究，完成了超过300个注册和开发策略制定项目。治疗领域涵盖如心血管和代谢，中枢神经系统，皮肤，消化，免疫，感染，***，肿瘤，呼吸，风湿和疫苗（和其他细胞和组织疗法）。
Clinipace刚刚庆祝了他们的10周年。如今，Clinipace其总部设在美国北卡罗莱纳州的Research Triangle Park，为横跨4大洲的27个国家提供服务。
因为对更高的数据准确度，经济高效的解决方案和更低的研发成本的需求在不断的增加，Clinipace还在持续的在全球扩张。
最后, Clinipace以正直透明、追求卓越绩效的企业文化邀请您的加入.
公司主页：*************************
最后, 丘以思以正直透明、追求卓越绩效的企业文化邀请您的加入.
应聘邮箱：kding@clinipace.com
联系方式
- Email：kding@clinipace.com
- 公司地址：地址：span广州