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Manager, Global Clinical Solutions

AstraZeneca
Remote friendly (Durham, NC)
United States
$98,893.60 - $148,340.41 USD yearly
Operations

Role Summary

Manager, Global Clinical Solutions (GCS) / IRT Lead. Enable efficient delivery of GCS services and technology for clinical programs. Lead Interactive Response Technology (IRT)/Randomization & Trial Supply Management (RTSM) systems across study lifecycle, covering set-up, maintenance, and close-out, including randomization, drug supply, and site/subject activities. Drive continuous improvement and ensure delivery to time, cost, and quality.

Responsibilities

  • Service delivery and lifecycle management of GCS processes, systems, and tools; ensure business continuity and compliance.
  • IRT/RTSM leadership: translate protocol requirements into system design, oversee configuration, UAT, go-live, maintenance, and decommissioning.
  • Vendor management: manage IRT providers for scope, quality, compliance, timelines, and SLAs; resolve issues and ensure on-time delivery.
  • Project management: plan and track milestones, manage risks/issues and changes, communicate clearly with stakeholders, and report progress.
  • Training and user enablement: deliver training on processes/systems/tools, facilitate knowledge sharing, define best practices, and maintain communications across GCS and AZ.
  • Process improvement: analyze usage and performance, identify efficiency opportunities, build business cases, and lead Lean-driven improvements.
  • Performance monitoring and change delivery: monitor KPIs, implement operational changes, embed continuous improvement and effective knowledge management.

Qualifications

  • Required: Bachelorโ€™s degree in life sciences/healthcare and 4+ years of experience.
  • Required: Strong project management, analytical and organizational skills; stakeholder management and presentation skills.
  • Required: Excellent written and spoken English.
  • Required: Proven risk and issue management; effective use of escalation and governance.
  • Required: Ability to build relationships and achieve outcomes without direct line authority; curious, self-motivated, and proactive.
  • Preferred: Expertise in GCS/IRT services; experience with Lean Six Sigma and Quality Management Systems (QMS).
  • Preferred: โ‰ˆ2+ years in drug development or clinical operations; understanding of ICH GCP.
  • Preferred: Experience in a complex, global organization and cross-functional collaboration.

Education

  • Bachelorโ€™s degree in life sciences/healthcare
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