Director or AD, Clinical Monitoring


Department: Clinical Operations

Position: Director of Clinical Monitoring, Clinical Operations

Position of Supervisor: Executive Director, Clinical Operations

Objective (existing reasons, definition, target):

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

The Requirement

Education / Experience

  • Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical
  • Eight 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

  • Demonstrate strong leadership and efficiently establish clinical monitoring team by bringing operational expertise
  • Lead team members to improve their monitoring efficiency and quality according to ICH GCP
  • Line Management of Clinical Operations Managers (COM)/ Associate Clinical Study Managers (ACOM)
  • Maintain a positive and results orientated work environment
  • Working closely with Clinical Operation Product lead to plan monitoring resource
  • Working with CROs and outsourcing team to plan FSP resource, if require
  • Implement and revise SOPs and monitor departmental compliance, if required
  • 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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