Clinical Trials Specialist

2 days ago


Melbourne, Victoria, Australia beBeeQuality Full time $102,596 - $122,476
Study Start Up Specialist

The Study Start Up Specialist plays a crucial role in country study start up activities and performs quality reviews of essential documents to ensure compliance with regulatory requirements.

  • Oversee and lead study start up activities in collaboration with country team members to improve site activation and maximize patient recruitment time.
  • Perform quality review of essential documents at start up and during the lifecycle of the study, ensuring adherence to ICH-GCP guidelines and local requirements.
Key Responsibilities:
  1. Country Study Start Up Activities: Lead country study start up activities to achieve greenlight for selected sites and ensure timely execution of clinical trial activities.
  2. Quality Review: Conduct quality reviews of essential documents at start up and during the lifecycle of the study to ensure compliance with regulatory requirements.
Required Skills and Qualifications:
  • Demonstrated experience in study start up activities and quality control processes.
  • Excellent communication and project management skills.
  • Able to work independently with minimal supervision and as part of a global team.
Benefits:

This is an excellent opportunity for a motivated individual to join our team and contribute to the success of our clinical trials.



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