Senior Director, Monitoring

1 month ago


Andover, Massachusetts, United States Ora Full time
Job Summary

We are seeking a highly experienced Senior Director, Monitoring to join our team at Ora. As a key member of our clinical operations team, you will be responsible for assisting with the planning, resourcing, and execution of our monitoring activities.

Key Responsibilities:

  • Provide strategic oversight and operational leadership for the development and maintenance of accurate operational plans, including department and project timelines and budgets.
  • Collaborate across the organization to plan, launch, and implement strategies for growth and new approaches to monitoring clinical trials, including Risk-Based Monitoring.
  • Develop and revise robust training, onboarding, and site management programs.
  • Supervise and mentor a team of monitoring managers across the United States and support harmonization of global processes.

Requirements:

  • Bachelor's Degree in a life science related field or equivalent combination of education, training, and experience.
  • Thorough knowledge of and experience in risk-based monitoring principles, including adherence to ICH E6(R2) requirements in monitoring plan development and deployment.
  • Experience managing globally for trial and project delivery.
  • Significant clinical research experience (comparable to 12+ years), including at least 5 years' experience in risk-based models, including remote and clinical monitoring.
  • Line management experience appropriate to the size and complexity of the clinical management group globally.
  • Valid Driver's License and Passport.
  • Travel is estimated at 25%.

We offer a competitive salary, comprehensive benefits package, and opportunities for career growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.



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