Clinical Operations Specialist

3 weeks ago


California, United States Bayside Solutions Full time
Clinical Trial Manager

Job Summary:

This is an exciting opportunity for an experienced Clinical Operations Professional to join our team at Bayside Solutions, Inc. As a Clinical Trial Manager, you will be responsible for overseeing Contract Research Organizations (CROs) and ensuring the successful execution of our clinical studies. If you have a strong background in clinical operations, Good Clinical Practice (GCP), and FDA regulatory requirements, we encourage you to apply.

Key Responsibilities:

  • Manage CROs and vendors to ensure timely and successful execution of clinical studies
  • Develop and implement clinical trial strategies to meet business objectives
  • Collaborate with cross-functional teams to ensure seamless study execution
  • Ensure compliance with FDA regulations, ICH Guidelines, and GCPs
  • Provide leadership and guidance to junior team members

Requirements and Qualifications:

  • BS or MS degree in a life science or related field
  • 5+ years of clinical operations experience in the pharmaceutical or biotech industry
  • Strong working knowledge of FDA Regulations, ICH Guidelines, and GCPs
  • Experience in managing CROs and vendors
  • Excellent communication and leadership skills

Preferred Qualifications:

  • Oncology experience
  • Experience in global clinical trial operations
  • Knowledge of APAC regulations

Bayside Solutions, Inc. is an equal opportunity employer.



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