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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