COM AD
百济神州生物科技有限公司BeijingUpdate time: August 20,2019
Job Description
Major Responsibilities
- Contributes to and has accountability for overall Clinical Operations strategy and performance against key metrics
- Maintains a positive and results orientated work environment
- Drives team members to improve their efficiency and effectiveness at prioritizing work and improving performance
- Develops training plans and programs across Clinical Operations to enhance project management skills
- Ensures that multiple, novel ideas on how to deliver on clinical trials are generated and considered
- Actively oversees the knowledge management process by ensuring information is captured, retained, and leveraged for future work
- Ensures operational processes, systems and standards are adopted and implemented consistently across trials
- Contributes to Clinical Operations and clinical trial sourcing strategy development and takes a lead role in vendor governance
- Champions a global mindset and approach across Clinical Operations to foster increased collaboration and consistency across BeiGene
- Ensures alignment with broader BeiGene strategic initiatives and business needs and provides recommendations or ideas on how Clinical Operations’ programs can generate greater value for BeiGene overall
- Ensures Clinical Operations thinking, and activities are aligned with overall business direction and priorities
- Identifies opportunities and initiatives within the broader organization that can be adopted/adapted by Clinical Operations as best practice; equally recommends best practices within Clinical Operations that if more broadly applied would benefit BeiGene as a whole
- Maintains a working knowledge of, and assures compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and SOPs
- Implements and revises SOPs and monitors departmental compliance
- Participates in formal staff performance review processes
- Communicates with internal and external staff effectively with a professional and collaborative approach.
- Escalates issues to BeiGene Senior Management team timely
- Demonstrates strong initiative in activities through the clinical trials and other company initiatives
- Proactively identifies potential issues and seeks improvement.
- Takes initiative for issue resolution within and outside the Clinical Operations department.
- Coordinates the risk management process encompassing proactive risk identification, evaluation (probability and impact) and mitigation plans
Supervisory Responsibilities:
Line Management of direct reports
Qualification
- Bachelor or higher degrees (life science preferred, including medicine, nursing, biology and laboratory technology)
- Fluent in written and verbal English
- 7 years or above in clinical or drug development in the biotech/pharmaceutical/CRO industry or the relevant clinical research field
- Minimum of three years of project management and/or clinical monitoring/ or startup experience (AD)
- Minimum of Five years of project management and/or clinical monitoring/ or start-up experience (Director)
职能类别: 生物工程/生物制药
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联系方式
上班地址:北京市朝阳区建国门外大街甲6号, 中环世贸中心D座
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