Global Study Director

3 days ago

Canada ICON Strategic Solutions Full time
Job Summary

ICON Strategic Solutions is seeking a highly experienced Global Study Director to lead and coordinate cross-functional study teams in the development and execution of clinical studies, focusing on Cell Therapy and CAR-T.

Key Responsibilities
  • Lead and coordinate cross-functional study teams to ensure the successful delivery of clinical studies, achieving milestones according to timelines, budget, and quality standards.
  • Contribute to vendor/ESP selection activities, including bid defense, and lead operational oversight to ensure appropriate control over vendor identification and selection.
  • 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.
  • 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.
  • 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.

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