Director, Training and Knowledge Management

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General Description

The Director, Training and Knowledge Management (Head of Global Clinical Operations Training) will develop, manage, and implement a training strategy and program across global clinical operations aimed at supporting GCOs on-boarding process and experience, role-based needs across global and regional roles while leveraging various training delivery methodologies and techniques (classroom, computer-based, “just in time” etc.)

This individual will serve as the Global Process Owner responsible for developing written policies and procedures outlining the training program as well serve as Business Owner of the training delivery platform.

This individual will partner closely with the Global Clinical Operations Leadership Team, Global Process Owners, Subject Matter Experts, Project Leads, CAPA leads and clinical trial teams in executing on the training strategy as well as anticipate specific training needs and to translate these needs into effective learning and development programs.

This individual will develop the framework and process for overseeing and training effectiveness performance indicators, lead the conduct of training needs gap assessments, and serve as the owner of the GCO training curriculum.

This role reports to the Executive Director, Global Clinical Operations Excellence.

Responsibilities

• Define and implement a global clinical operations training strategy which includes Implementation, Communication and Change Management plans.
• Develop, coordinate, and implement relevant structured global clinical operations core learning and development programs based on global, regional, and individual role needs. This includes training on global clinical operations policies, procedures and processes, compliance topics, functional job aides, and 'refresher trainings, as needed.
• Launch GCO BeiGene Academy (Training Platform) across Global Clinical Operations and serve as the partner to the vendor/partner as needed.
• Launch the GCO Investigator Site Portal Platform aimed at serving as a communication and training tool in support of delivering study specific training and material.
• Develop and maintain relationships with training colleagues across HR, Quality Assurance and Clinical Development functional areas – with a focus on building a functional training network.
• Provide input to standard operating procedures as appropriate and work in parallel to support roll out and implementation
• Serve as GCO Training SME during Audits and Global Health Authority Inspections which includes leading responses to findings/observations as needed.
• Establish Training related KPIs/KQIs and associated Training Metrics Dashboard to ensure training effectiveness on a routine basis.
  
  

Requirements

• Bachelor’s Degree required or Masters degree preferred.
• 10 years experience leading and implementing functional training strategies and programs.
• Experience in developing training material and content
• Experience in working in learning management systems
• Extensive experience in GCP training policy and process development
• Significant experience in global clinical operations activities.
• Prior leadership experience leading matrix organizations
• Excellent communication and presentation skills.
• Excellent knowledge of FDA and ICH/GCP regulations, guidelines and other applicable regulations
• Ability to execute and follow-through to completion
• Independently motivated and detail oriented
• Ability to work effectively in a collaborative team environment
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment
• with changing priorities
  
  

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.