Manager, Clinical Monitoring


Department: Clinical Operations

Position: Manager of Clinical Monitoring, Clinical Operations

Position of Supervisor: Director, Clinical Operations

Objective (existing reasons, definition, target)

Manager of Clinical Monitoring, Clinical Operation is accountable for the delivery of the responsible team

The Requirement

Education / Experience

  • Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical
  • Five or more years of clinical research experience in the Pharmaceutical or CRO industry
  • Demonstrated strong project management capabilities and capable of training / mentoring others
  • Demonstrated experience working on a team across multiple functional areas

Special knowledge/Skill

  • Excellent communication, relationship building and interpersonal skills
  • Excellent organizational skills and ability to prioritize and multi task
  • Fluent in English (writing and speaking)

Responsibility Scope

  • Lead and motivate team members to improve their monitoring efficiency and quality according to ICH GCP
  • Line Management of Senior/ Clinical Research Associate (S/CRA)
  • Maintain a positive and results orientated work environment
  • Implement and revise SOPs and monitor departmental compliance, if required
  • Perform Quality Oversight visits, if require
  • Participate in formal staff performance review processes
  • Communicate with internal and external staff effectively with professional and collaborative approach. Escalate issues to BeiGene Senior Management team timely
  • Demonstrates strong initiative in activities through the clinical trials and other company initiatives
  • Proactively identify potential issues and seek improvement. Take initiative for issue resolution within and outside the Clinical Operation department. Coordinate the risk management process encompassing proactive risk identification, evaluation (probability and impact) and mitigation plans
  • Provide ongoing mentoring and training to the responsible team and other individuals, as appropriate
  • Take accountability and ownership for tasks within the job description, and other tasks assigned according to business needs
  • Being a team player and help others when required

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