Related skills
qa inventory management validation gmp irt📋 Description
- Lead IRT strategy during protocol development and study start-up.
- Translate protocol requirements into IRT specifications with functional leads.
- Define IRT inventory strategy with Clinical Supply Chain (buffer, overage, resupply thresholds, expiry management).
- Ensure packaging configuration is reflected in the IRT system.
- Own and govern all IRT enhancements and changes after go-live.
- Assess the operational, site, and supply chain impact of proposed changes.
🎯 Requirements
- Bachelor's degree in Life Sciences, Engineering, or related field.
- 5+ years in clinical trials with at least 3 years IRT experience.
- Strong knowledge of clinical supply chain operations and multi-depot studies.
- Independent self-starter who leads ad-hoc teams with good judgment.
- Systems thinking across Ops, Sites, and Supply Chain; translate protocol to ops logic.
- Vendor management, technical documentation, and IRT data changes with minimal disruption.
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