COM AD
百济神州生物科技有限公司BeijingUpdate time: August 20,2019
Job Description
北京市 朝阳区

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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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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