北京招聘

ESSENTIAL JOB FUNCTIONS:

1. Conducts and documents assigned audits of the projects and operational processes in accordance with approved procedures, schedules and formats. Specific audit areas will include but not be limited to:
? Investigator Sites
? Trial Master and Project Management Files
? Project Databases (and their development)
? Data Management Activities and documentation
? Safety Reporting
? Final/Clinical Study Reports
? Staff Training Records
? Vendors

2. Writes and issues audit reports in accordance with standard Company formats and timelines, ensuring clear communication of audit findings to the relevant project team members and/or functional area management. Reviews responses to audit findings for appropriateness and completeness.

3. Maintains documentation and status of QA auditing activities as outlined by applicable SOPs and WIs.

4. Serves as a mentor to less experienced QA Auditors.

5. Serves as Lead Auditor on team-based audits and/or for project audits.

6. Manages assigned quality issues in accordance with Company requirements.

7. Hosts sponsor audits as assigned.


OTHER RESPONSIBILITIES:

Performs other work-related duties as assigned. Extensive travel may be required (at least 50%), domestically and internationally


EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:


Requires a Bachelor's degree in a science/health care field with significant experience in clinical quality assurance auditing, including investigator site audits, audits of data management activities and vendor audits. Requires strong and comprehensive knowledge of applicable Good Clinical Practice regulations and Guidelines as well as medical terminology. Ability to handle multiple tasks to meet deadlines in a dynamic environment is a must. Strong organizational, presentation, documentation and interpersonal skills with diverse cultures needed. Ability to negotiate and provide constructive feedback is essential. Must be able to work as part of a team as well as independently. Well-developed communication skills and the ability to write and present concise, accurate reports and other necessary documentation. Proficient use of computer and Microsoft software programs and Email and voice mail communication systems is a must. Ability to work nights and week-ends as needed.

公司介绍
    华翌咨询服务有限公司Synergy Consulting
华翌咨询服务有限公司是国内著名的人力资源和管理咨询服务公司，长期致力于为世界500强公司和国际知名企业提供高中级人才访寻解决方案与服务。专注于消费品，医药，IT，媒体等行业的职位我们在广州和上海，北京，深圳分别设有办事处，也将会在国内更多城市成立办事处，为更多的客户提供人力资源服务。
 
    Synergy China is a professional and leading consulting company dedicating to provide human resources service including executive search, recruiting outsourcing and consulting. Our business areas focus on IT/ Telecom, AD/PR/Media, Footwear & Apparel, Sourcing & Retail, Chemical & Pharmaceutical, Manufacturing & FMCG, Real Estate, and other industries.
    Our business covers mainland, Hong Kong, Taiwan and some countries in South East Asia. Base on our slogan ‘Know the Industry, Know the People’, we are developing and growing through years of continuous effort and study. Our efficient team of experts serves our proud clients with excellent product and quality service.


招聘职位如所述。