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Global Study Director

2 months ago

Canada ICON Strategic Solutions Full time

ICON plc is currently hiring a Global Study Director with experience in Non-Oncology, CAR-T clinical studies.

As a Global Study Director working in an embedded model with a top global pharma, you will lead and coordinate a cross-functional study team to drive the progress and successful delivery of clinical studies, focusing on Non-Oncology, CAR-T. You will oversee vendor selection, provide operational oversight, and ensure key milestones are achieved within timelines, budget, and quality standards. Additionally, you will collaborate with other teams to enhance efficiency and maintain appropriate oversight of outsourced studies, ensuring all processes align with regulatory and company guidelines.

Day-to-day responsibility will include, but is not limited to:

  • Lead and coordinate a cross-functional study team of experts to ensure the clinical study progresses as planned, 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.
  • For outsourced studies, 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 for this role include:

  • 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