长沙招聘

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.

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.

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. 举报 分享

万宝盛华大中华有限公司，1997年服务启航于香港和台湾。迄今服务覆盖上海、北京、广州、深圳等逾20座直营城市。我们的大股东万宝盛华全球（ManpowerGroup Inc. NYSE:***）是全球人力资源解决方案领导者，拥有70年服务经验。凭借万宝盛华全球的声誉及行业经验，万宝盛华大中华深耕本土20余年。2015年，万宝盛华大中华战略联盟中信产业基金，总部落地上海，服务网络覆盖两岸三地130余城市逾两万家企业。我们始终致力于释放人才的发展潜能，凭借灵活用工、人才寻猎、招聘流程外包、人才管理及培训发展等人力资源综合解决方案，广受业界赞誉，屡次荣膺“亚太人力资源领军企业”。