Area Clinical Studies Coordinator

5 days ago

Sydney, New South Wales, Australia beBeeRegional Full time $100,000 - $150,000
Job Overview

The Regional Study Setup Lead is responsible for the timely and effective delivery of setup activities for assigned pipeline and global clinical studies within the region. This role reports to the Regional Head and serves as a single point of accountability for site setup activities within the assigned studies.

Main Responsibilities:

  • Oversee and drive activities of regional specialists for assigned trials.
  • Identify and communicate issues impacting delivery and provide proposed solutions.
  • Work with regional and country leadership to identify training needs of regional specialists and standardize training solutions.
  • Accountable for timely, quality delivery of setup activities of assigned clinical studies.
  • Collaborate with key stakeholders to establish regional/site activation plans, including risk assessments and mitigation planning.
  • Build regional-level ICF samples, review IRB/EC comments, and route for approval.
  • Drive setup activities, including timely site selection and activation, EC submissions, document collection, and query responses.
  • Provide regional setup updates and metrics to Regional Director and Global Leads.
  • Run regional setup meetings and drive priority action items between meetings.
  • Collaborate with Global Site Contracting & Purchasing, CTS, and Regulatory Affairs to ensure alignment.
  • Lead quality management through risk-based thinking for assigned studies.
  • Drive standardization in regional setup process and training, sharing best practices and lessons learned.
  • Maintain setup performance metrics and KPIs for assigned studies.
  • Ensure audit/inspection readiness.
  • Maintain intelligence database and Vault EDLs for countries and sites within the region.

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