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: Bachelorโs 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: โ2+ years in drug development or clinical operations; understanding of ICH GCP.
- Preferred: Experience in a complex, global organization and cross-functional collaboration.
Education
- Bachelorโs degree in life sciences/healthcare