Director of Clinical Trial Operations

2 days ago


Dublin, Dublin City, Ireland Healthcare Businesswomen's Association Full time

About the Job

We are seeking an experienced Associate Director to join our Clinical Trials team. As a key member of the team, you will be responsible for managing all clinical vendor-related aspects of global clinical trials.

Responsibilities

  1. Lead the CTT vendor sub-team, overseeing the translation of vendor-related protocol sections into external service requirements.

  2. Work closely with the study lead and other team members to ensure successful study outcomes within schedule, quality/compliance, and performance standards.

  3. Collaborate with vendors to develop Study Specification Worksheets, ensuring effective vendor cost control and budget review.

  4. Support activities related to audits and inspections, including user acceptance testing for eCOA and IRT systems.

  5. Develop and maintain relationships with key vendors, negotiating contracts and ensuring compliance with GxP and ICH regulations.

Requirements

  1. 5+ years of experience in clinical operation processes and direct vendor management.

  2. Excellent knowledge of GxP and ICH regulations, with a strong understanding of clinical trial design and mapping to supplier requirements.

  3. User Acceptance Testing (UAT) skills for eCOA and IRT systems.

  4. Experience with site collaboration, site activation, and external data generation processes.

  5. A good understanding of third-party data transfer specifications and reconciliation processes.

Skills

  • Budget Management
  • Clinical Trials
  • Negotiation Skills
  • People Management
  • Process Improvement
  • Project Planning
  • Vendor Management
  • Waterfall Model


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