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Regulatory Submissions Expert

1 week ago

Queenstown, New Zealand Medpace Full time

Key Responsibilities

The Study Start Up Submissions Coordinator will play a key role in ensuring the smooth start-up of clinical trials at MEDPACE. Key responsibilities include:

  • Preparing and submitting regulatory applications to Ethics Committees and Regulatory Agencies
  • Coordinating with global study teams and personnel on study progress
  • Identifying and mitigating risks to site activations
  • Providing expertise and guidance to global study teams in ethics and regulatory submissions
  • Reviewing and finalizing essential documents required for site activation

Requirements

To be successful in this role, you will need to have a Bachelor's degree in a science field or equivalent combination of education and experience. Additionally, you should have at least 2 years of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site as a study coordinator.