上海招聘

POSITION RESPONSIBILITIES:

? Drives and leads all aspects of Data Management including:

? CRF specification and design and the specification of Edit Check requirements.

? assisting with the execution of validation and testing procedures of clinical database, eCRF and edit checks (eg, functional and user acceptance tests).

? ensuring the effective & efficient execution of data review and discrepancy management in accordance with the Data Management Plan and Data Review Guidelines.

? overseeing or mentoring data review requirements and processes to ensure delivery of highest quality of data.

? Ensures the timely and successful execution of data management objectives.

? Participating in/leading project meetings to ensure clear overview of progress, risks and mitigation strategies by all participants for all data management

related deliverables. Ensures clear communication on project-status to sponsors or senior stakeholders.

? FDA and Quality audits that involve data management.

? Creation and maintenance of all essential data management documentation including CRFs and annotated CRFs, Data Management Plans, Data Review Guidelines, CRF Completion Guidelines, Data Entry Guidelines, UAT Plans, and other study specific work instructions or guidelines for assigned projects to ensure compliance to quality system.

? Remaining current on data management technology, processes, and best practices via reading, presenting, giving trainings, membership in professional organizations, etc.

? Improving data management best practices/standards and Standard

Operating Procedures compliance (eg, use of standardized Case Report Forms, univariate versus multivariate edit checks, reusable edit check specifications).

? Additional responsibilities including a focus on process improvement projects, enterprise wide initiatives, and program level data management.

? Identifying and monitoring key performance indicators. Driving continuous improvement and results via key performance metrics.

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BASIC QUALIFICATIONS:

EDUCATION REQUIRED:

Bachelor’s degree

YEARS OF EXPERIENCE:

4-7 years experience (2-5 years withMasters)

SPECIALIZED KNOWLEDGE REQUIRED

· Clinical database systems knowledge: advanced level proficiency with relational databases (EDC) systems. Big-picture and detail-oriented view of data management processes, tools, and procedures.

凯捷集团创建于1967年，是全球最著名的管理咨询、技术和外包服务的供应商之一。凯捷全球员工超过15万人，2012年营业额超过103亿欧元，在专业服务领域中位居世界前三名，并在巴黎证券交易所上市，荣列道琼斯指数和道琼斯欧洲指数等著名指数。目前在全球39个国家拥有分公司，且合并了安永咨询。