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Clinical Operations Manager

1 maand geleden


Zwolle, Overijssel, Nederland BeiGene Voltijd

BeiGene is seeking a highly motivated and experienced Clinical Operations Manager to join our team in the Netherlands. As a key member of our clinical operations team, you will be responsible for managing study start-up and trial monitoring staff, ensuring timely and complete IRB/EC submissions, and maintaining inspection readiness.

Key Responsibilities:

  • Manage study start-up and trial monitoring staff in accordance with BeiGene's policies and applicable regulations.
  • Participate in the selection for hiring new employees and ensure proper onboarding and training.
  • Manage the quality of assigned staff's clinical work through regular review and evaluation.
  • Provide country-specific study start-up expertise to study start-up team leads and project teams.
  • Collaborate with Regional Clinical Operations Manager and clinical study sites to achieve timely and complete IRB/EC submissions.

Requirements:

  • Minimum of 5-7 years progressive experience in clinical operations within the biotech/pharmaceutical sector in the Netherlands.
  • Prior clinical trial experience, including experience in a management/leadership capacity.
  • Experience in oncology is highly recommended.
  • Ability to work independently and effectively handle multiple priorities in a fast-paced environment.

Education and Skills:

  • Bachelor's degree (or equivalent) or higher in a scientific, medical, or healthcare discipline.
  • Excellent interpersonal skills, strong organizational skills, and fluency in English (writing and speaking).

Travel: up to 30-40%

Competencies:

  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity