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职位要求：医药相关领域，英语流利。
Position: Risk Assessment Manager Assistant
3 positions
Report to: Associate Risk Assessment Manager
Location: Beijing
Position Purpose:
- The purpose of this position is to drive for business quality and efficiency by increasing compliance with GxP (GLP/GCP), established quality and ethical standards, while gathering and evaluating global clinical study and global (cross functional) process related data in liaison with GD and GDD functions involved to support a knowledge based monitoring/audit process and to harmonize (cross functional) processes.
Major tasks of Position:
- Gather global clinical study and process related data in liaison with GD and GDD functions involved out of different databases in different formats and ensure conversion in readable formats
- Develop spreadsheets to evaluate available datasets according to customer needs
- Ensure that indicators discussed with GD and GDD functions involved on an ongoing basis and that all relevant parameters (e.g. thresholds, weighting) are considered
- Create dashboards to focus on areas with increased risks to support a knowledge based monitoring/audit process and to harmonize (cross functional) processes
- Support analyzing data and report results to corresponding customers
- Support all functions involved to analyze relevant global clinical studies and processes as a basis for a risk management process to promote regulatory compliance
- Prepare training activities Global R&D Quality Compliance Management staff members and corresponding customers in risk assessment
Knowledge or Know-how Required:
- The position requires at least 4 years experience in clinical research activities (e.g. monitor, study coordinator) or in a Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP) environment. At least 1-2 year must include a proven record in GCP compliance activities (such as clinical trial monitoring or study coordinator activity).
- Basic knowledge and experience in the application of good clinical practice (GCP) requirements is required (e.g. ICH, FDA, etc), as is familiarity with the essential documents related to clinical studies. The incumbent should be familiar with medical terminology and routine medical tests and procedures. Familiarity with computerized clinical data collection systems and biomedical statistics is helpful.
- Oral and written proficiency in the English language is required. Incumbent must also be confident and adept in the use of computerized databases and other applications. Professionalism is mandatory, as the incumbent must interact directly with all levels of Bayer staff, up to and including Vice President level and with clinical investigators, providers of services to Bayer and others. The ability to develop interdepartmental relationships is critical.
- Good project management skills, including effective planning and organizational skills, attention to detail and excellent follow through.
- The incumbent must be aware of the key differences in how business is practiced various countries to work effectively with various cultures. It is essential to be aware of the key cultural customs and practices that will create an effective working relationship and effectively represent Bayer as a multinational corporation.
- In addition, the incumbent must be able to establish strong credibility with all functions of Global Development and Global Drug Discovery world-wide in order to gather the information necessary to promote implementation of corrective and preventive actions that will lead to better performance of the processes.
Contact Person: Kelly Guo (010-59271344, 13910519023)
Email: Kellyguo@
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