长沙招聘

职位描述：
世界第三大的制药企业。总部设于巴黎，该集团是一家全球领先的多元化医药健康企业，致力于医药产品的研究、开生产以及销售；专注于患者需求，传播健康。它的业务覆盖疫苗、处方药、健康药业产品和劝物保健品，拥有10万余名员工、遍及100多个国家。2004年营业额超过250亿欧元。致力于医药产品的研究、开发、生产以及销售，产品主要覆盖七个领域：心血管疾病，血栓形成，肿瘤学，糖尿病，中枢神经系统，内科疾病和疫苗。

JOB DESCRIPTION:
Job Title: Study Data Manager

JOB PURPOSE:
The Study Data Manager 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 ACCOUNTABILITIES:
Major duties & responsibilities:
1. Primary contact between CDM 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,CRF design, SSD, PM, DMS) are consulted appropriately on study decisions. Implements and oversees processes and coordinates activities in conjunction with the study team and Project Leader. Proposes solutions for data management issues that arise during the conduct of a study
2. In charge of the development of protocols, 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 CDM study teams (Clinical Data Coordinators, contractors) assigned to support studies.
4. Continually evaluates CDM 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. Deputizes for the Project Leader Data Management, when appropriate. Participates in the implementation of department initiatives.

JOB-HOLDER ENTRY REQUIREMENTS:
Knowledge and skills:
？ Clinical Data Management System experience (e.g., Clintrial, Oracle Clinical) and understanding of database/programming concepts preferred. Expert in the use of Data Management applications and database/file structures; able to use SQL, SAS and other programming/query languages; 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

Formal education and experience required:
？ Bachelor degree, preferably in a life science or mathematics-related area (e.g., computer sciencecs) and equivalent experience(at least 2 years) in clinical data management.
？ Oral and written English communication skills.

Knowledge and skills desirable but not essential:
？ Knowledge of sanofi-aventis SOPs.
？ Remote management experience.
？ Management of outsourced activities. 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”。