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Manager, Global Clinical Solutions

Location Durham, North Carolina, United States Job ID R-242244 Date posted 18/12/2025

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 - set-up, maintenance, and close-our - covering randomization, drug supply, and site/subject activities. Drive continuous improvement and ensure delivery to time, cost, and quality.


We are recruiting IRT Leads to oversee our Interactive Response Technology (IRT)/ Randomization & Trial Supply Managment (RTSM) systems that manage randomization, drug supply, and site/subject activities for clinical studies. In this role, you will support study teams through the full lifecycle - set-up, maintenance, and close-out - of the IRT system tailored to each clinical protocol. You will drive vendor management, ensuring performance, quality, compliance, and timely delivery across IRT providers. Successful candidate requires strong project management skills, including planning, risk/issue management, stakeholder communication, and on-time execution.

Key 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.


Essential qualifications

  • Bachelors degree in life sciences/healthcare and 4+ years of experience.

  • Strong project management, analytical and organizational skills; stakeholder management and presentation skills.

  • Excellent written and spoken English.

  • Proven risk and issue management; effective use of escalation and governance.

  • Ability to build relationships and achieve outcomes without direct line authority; curious, self‑motivated, and proactive.

Desirable

  • Expertise in GCS/IRT services; experience with Lean Six Sigma and Quality Management Systems (QMS).

  • ≈2+ years in drug development or clinical operations; understanding of ICH GCP.

  • Experience in a complex, global organization and cross‑functional collaboration.

The annual base pay for this position ranges from $98,893.60 - $148,340.40. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

19-Dec-2025

Closing Date

30-Jan-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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