Clinical Trials Director

3 days ago


Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

About the Role: As a key member of our clinical trial team, you will independently manage all vendor-related aspects of global clinical trials to deliver study outcomes within schedule, quality, and performance standards.

Your Responsibilities:

  • Serve as the leader of the CTT vendor sub-team, working closely with the study lead and other team members throughout the duration of the study.
  • Review and translate vendor-related protocol sections into external service requirements and review vendor specification documents.
  • Work with Vendor Start-up Manager on developing the Study Specification Worksheet to aid the bid process.
  • Accountable for vendor cost control, budget review, invoice reconciliation, and PO close-out.
  • Support activities related to audits and inspections.

Requirements:

  • 5+ years of experience in clinical operation processes and direct vendor management, including direct management of key clinical study vendors.
  • Excellent knowledge of GxP and ICH regulations.
  • User Acceptance testing for eCOA and IRT.
  • Site collaboration and site activation.
  • Good understanding of external data generation and data validation processes.


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