Global Clinical Trial Operations Manager

1 week ago

Sydney, New South Wales, Australia beBeeClinical Full time $98,765 - $123,456

**Job Overview**

We are seeking a skilled Clinical Trial Operations Manager to lead the planning, coordination and execution of study start-up activities in a standalone country or satellite country.

This role will oversee all study start-up activities of assigned projects in close collaboration with the global study team and other stakeholders.

  • Schedule and coordinate study start-up activities to ensure timely completion
  • Ensure compliance with GCP/ICH and regulatory requirements
  • Lead the local study start-up team and ensure high-quality clinical trial documentation/data delivery

Key performance indicators include:

  • Performance against study commitments at the country level
  • Delivery of study milestones in adherence to prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
  • Timely submission and delivery of high-quality clinical trial documentation/data

Required Skills and Qualifications

A degree in a scientific or health discipline is required. Advanced degrees with clinical trial experience and/or project management are desirable.

Candidates should have a minimum of 5 years' experience in clinical operations, including project management and/or monitoring clinical trials.

Fluent written and spoken English is essential.

Desirable Skills and Knowledge

Strong project management capabilities, with the ability to problem-solve and mediate complex issues.

Thorough understanding of international drug development processes, including GCP/ICH, FDA/EMA, local/National Health Authorities regulations.

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