- Provides assigned study teams with onboarding training and tools to aid in the adoption of RBQM.
- Facilitates risk management with the relevant stakeholders for identification of critical to quality factors, and identification, evaluation, control, communication, review and reporting of risks.
- Collaborates with CRAs, Central Statistical Monitors, Data Management, vendors, process owners and others as needed to analyze risks and issues using quality performance data, to identify follow up actions and to oversee completion of identified actions.
- Drafts, maintains, and archives the documentation of risk management activities e.g., risk/issue(s), controls, findings, escalations, tracking and resolution utilizing RBQM tools and following BeiGene SOPs.
- Trends risks and issues across related entities.
- Supports the study team and other contributors to clinical development in optimization of controls applied based on risk evaluation. For example, optimizing the application of source data verification and source document review.
- Supports the study team in optimizing the RBQM model including acting as a change champion and subject matter expert for a risk-based environment.
- Develops and leads culture change and communication activities with stakeholders.
- Conducts ad hoc risk assessments as needed to support clinical development.
- Additional activities as needed to support business goals.
- Matrix influence across levels, functions, countries and time zones
- 5-10 years leading risk assessments in the pharmaceutical industry
- Prior experience deploying risk-based quality management programs across clinical development preferred
- Ability to work independently to complete management and oversight activities
- Experience working and communicating within cross-functional teams
- Knowledge of overall clinical trial management process, understanding of the protocol and other clinical trial related plans and documents
- Critical thinking and analytical skills to understand and analyze complex data and provide insight into risk reports, trends, and outliers in data
- Therapeutic area specific experience and knowledge – Oncology/Hematology preferred
- Ability to use the relevant technology and risk-based tools/platforms effectively
- Proven track record in delivering agreed results against a plan and timeline
- Understanding of ICH and regulatory environment
- Problem-solving skills
- Self-management skills
- Ability to work in global team environment
- 团队协作
- 提供并征求坦诚及可行的反馈
- 自我认知
- 兼容并蓄
- 积极主动
- 开拓精神
- 持续学习
- 拥抱变化
- 结果导向
- 分析性思维/数据分析
- 卓越财务
- 清晰沟通
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
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Risk Based Quality Management Lead - Chaoyang, 中国 - BeiGene
描述
Job Description:
General Description:
The Risk Based Quality Management Lead will create risk assessments for any entity in clinical development, follow up on quality signals, issues and open actions and contribute to the advancement of the RBQM program.
Essential Functions of the Job:
Qualification Required:
Supervisory Responsibilities:
Computer Skills: Windows, Offices, Analytics Tools
Other Qualifications:
Travel: 0-20%
百济神州全球胜任力
当我们通过以下十二项全球胜任力,展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时,我们就能帮助全世界更多患者获得更多负担得起的药品。
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
求职者隐私申明:
百济神州致力于尊重和保护求职者的个人信息权利,并承诺依据合法、正当、必要和诚信的原则处理求职者的个人信息(包括个人敏感信息,如有)。更多详情,敬请查阅百济神州《求职者隐私政策》。
由于百济神州在全球范围内开展业务,我们需要基于集团人力资源统筹管理的合理业务目的而向百济神州关联公司(BeiGene Ltd.)提供求职者的简历及求职信息,求职者的信息将被存储在位于中国境外(目前位于美国)的Workday数据库。如需行使中国法律规定的各项个人信息权利,可通过联系BeiGene Ltd.
Due to the reasonable business need for human resource management as a result of BeiGene's global operation, job applicants' resume and job application relevant information may be provided to the BeiGene affiliate (BeiGene Ltd.), and the aforementioned data will be stored in Workday (currently located in the U.S.). If the job applicant wishes to exercise his/ her personal information rights provided under PRC laws, he/ she may contact BeiGene Ltd. via
如您主动向我们提供您的个人信息,则视为您已经理解并接受百济神州《求职者隐私政策》以及相关个人信息处理规则(尤其是向中国境外提供个人信息)。如您主动向我们提供其他求职者的个人信息,则视为您确认相关人员已经理解并接受百济神州《求职者隐私政策》以及相关个人信息处理规则(尤其是向中国境外提供个人信息)。
If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to BeiGene's Job
