长沙招聘

Responsiblities:
? Performs tasks related to all aspects of the clinical trial data management process from study start up to database lock for both paper-based and EDC trials.
? Represents Data Management on Clinical Trial teams.
? Designs CRF and clinical database structures for data acquisition and data entry.
? Identifies and resolves data flow process issues in collaboration with the project team.
? Defines data handling conventions, edit checks, quality acceptance and auditing criteria for electronic data as well as procedures for handling exceptions for violations to the standard metadata and identifies and requests additions to standard metadata.
? Creates standard and ad hoc reports to efficiently identify outstanding queries, query types per site, etc.
? Resolves discrepancies and unresolved issues that arise during data entry.
? Assesses and reports on data outlier values.
? Identifies SAEs and works with Safety to ensure reporting.
? Identifies areas of manual data review where electronic checks are not effective
? Uses available tools, systems and processes in support of the coding of medical terms
? Communicates with vendors to define required file format and content specifications for electronic files and establishes schedule and process for data transfers.
? Participates in the identification, review and evaluation of new data management technologies.
? Follows up on query responses and errors identified in data cleaning.
? Drafts new Data Management Plans based on templates and Plans for similar protocol types.
? Liaises with third-party vendors such as central laboratories in a project-manager capacity.
? Monitors timelines to ensure data management-related deadlines are met.
? Participates in the development and maintenance of Standard Operating Procedures (SOPs) related to data management activities

Qualifications:
? Education and experience should include a minimum of a Bachelor’s Degree and a minimum 2-3 years of related industry experience with a strong emphasis in Clinical Data Management
? Must have an excellent understanding of the conduct of clinical trails, clinical trial related systems and procedures, the regulations and be able to understand the nature of the drugs being studied.
? Must have a strong computer background with experience utilizing at least one commercial data management system
? Ability to prioritize and manage multiple tasks
? Must have demonstrable supervisory experience and excellent people skills and demonstrate the ability to work successfully in a team environment.

本公司为外商独资企业，总部位于美国马里兰州，是一家全球性医药研发咨询服务机构（CRO）。为满足业务发展需求，公司在全国各地广泛招聘各方面人才，包括临床监查、商务拓展、注册等职位，欢迎有才、有志者加盟。在北京，公司位于海淀区上地，工作地域优越、交通便利。

本公司发展以人为本。对优秀人才，公司提供：
优厚的工资、福利待遇（与跨国制药企业相当）
极大的个人发展空间与职务提升的潜力
多方面培训机会（包括去美国总部培训的安排）
和谐愉快的工作环境与团结协作的团队精神

本公司处于快速发展阶段，要求员工具备以下优良素质：
事业心强、富有敬业精神
有独立工作的能力与自我开拓精神
善于沟通
能吃苦耐劳

公司对有跨国公司经验的申请者优先考虑，有意者请发简历到所述邮箱并注明城市和所申请职位。

有符合所述条件者请发简历到本公司，否则不予考虑。一经录用，待遇优厚。

Accelovnace (China) Co. Limited is an international pharmaceutical service company. It is a CRO/SMO (a clinical research organization and site management organization). It is focused on global clinical trial management for western pharmaceutical and biotechnology industry; as supplementary, it also provides service to local pharmaceutical companies for clinical trial management.

The Company is registered in Beijing as a wholly foreign owned enterprise. Its parents company is headquartered in Rockville, Maryland of the USA. Currently, the Company has 12 wholly self owned clinical sites throughout the United States. It is starting up its China operation in Beijing from June. 2005.

As a US originated CRO/SMO, Accelovance always pursues the best clinical practice in clinical trial management, pursues quality, speed and cost-effective for its clients; demonstrate its professionals to its clients and investigators from details. With advanced patient and project management system, with electronic trial management system and web-based data capture system, with experienced and dedicated employees and systemic training and strong support from its parent company in the US, Accelovance (China) is able to deliver phase I to phase IV clinical trial operations for all kinds of clients.

In the same time, Accelovance pays attention to personal advancement for its staff from competitive salary and benefit to long-term professional development opportunity, from systemic training to team building and open-minded culture. Accelovance is confident to abstract elites in clinical research industry.

For more details, please visit the Company's website at www.accelovance.com.cn



Notice:
Applicants must fit for requirements, if not, please do not send your CV to us, thanks!

具有新药临床试验经验者优先录用