Senior Clinical Trial Operations Manager

2 weeks ago


Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

Are you ready to take on a challenging role as a Senior Clinical Trial Operations Manager? We are seeking a skilled professional to lead vendor-related aspects of global clinical trials. As a Senior Clinical Trial Operations Manager, you will be a core member of the Clinical Trial Team, independently managing all vendor-related tasks to deliver study outcomes within schedule and quality standards.

About the Role

Key Responsibilities

  1. You will serve as the independent leader of the CTT vendor sub-team and a key member of the clinical trial team, working closely with the study lead and other team members throughout the duration of the study.
  2. You will review and translate vendor-related protocol sections into external service requirements.
  3. You will work with the Vendor Start-up Manager on developing the Study Specification Worksheet to aid the bid process.
  4. You are accountable for vendor cost control, budget review, invoice reconciliation and PO close-out.
  5. A minimum of 3+ years of experience in clinical operation processes and direct vendor management is required.
  6. Excellent knowledge of GxP and ICH regulations is necessary.
  7. User Acceptance testing for eCOA or IRT is also required.
  8. Site collaboration and site activation are additional responsibilities.
  9. A basic understanding of external data generation and data validation processes is preferred.

Benefits

As a Senior Clinical Trial Operations Manager at Novartis Farmacéutica, you will enjoy a comprehensive benefits package, including competitive compensation, health insurance, and retirement savings plan.



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