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Global Study Director

2 months ago

Canada ICON Strategic Solutions Full time
Job Summary

We are seeking a highly experienced Global Study Director to lead and coordinate cross-functional study teams at ICON Strategic Solutions. As a key member of our clinical research team, you will be responsible for driving the progress and successful delivery of clinical studies, focusing on Non-Oncology, CAR-T.

Key Responsibilities
  • Study Leadership: Lead and coordinate cross-functional study teams to ensure clinical studies progress as planned, achieving milestones according to timelines, budget, and quality standards.
  • Vendor Management: Contribute to vendor/ESP selection activities, including bid defense, and lead operational oversight to ensure appropriate control over vendor identification and selection.
  • Study Oversight: Be the primary point of contact for the CRO Study Manager to ensure study delivery according to agreed timelines, budget, and quality standards, maintaining proper oversight throughout the study lifecycle.
  • Study Planning: Develop and maintain relevant study plans, including input into study-level quality and risk management planning, ensuring risk response strategies and issue escalation pathways are clear to the study team.
  • Performance Monitoring: Oversee study-level performance against agreed plans, milestones, and KPIs using tracking systems, and communicate any risks to timelines or quality, along with proposed mitigations.
Requirements
  • University degree (or equivalent), preferably in medical or biological sciences
  • At least 3 years of experience in global study leadership and team leadership
  • At least 7 years of clinical trial management experience
  • CAR-T study experience surrounding immunology and respiratory disease is required
  • Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements
  • Proven project management experience and training
  • Strong abilities in establishing and maintaining effective working relationships with senior stakeholders