- Company Name
- ALSINOVA CRO
- Job Title
- IRT Specialist in Clinical Supply Chain - Montréal, Canada (F/M)
- Job Description
-
**Job Title:** IRT Specialist – Clinical Supply Chain
**Role Summary:**
Configure, maintain, and support complex Interactive Response Technology (IRT) systems for clinical trials. Serve as the subject‑matter expert for study randomization, blinding/un‑blinding, and supply strategy, ensuring data integrity, regulatory compliance, and efficient trial execution.
**Expectations:**
- Independently manage end‑to‑end IRT study setups, including protocol amendments.
- Proactively identify issues, propose solutions, and drive continuous improvement.
- Provide timely help‑desk support and on‑call coverage.
- Produce and maintain SOPs, training materials, and eTMF documentation.
- Collaborate with cross‑functional teams and external vendors to resolve system issues and implement enhancements.
**Key Responsibilities:**
- Configure and maintain complex, multi‑regional or adaptive IRT study designs.
- Develop and execute supply strategies to prevent stock‑outs, minimize waste, and optimize shipments.
- Deliver face‑to‑face IRT training to statisticians, supply managers, and other stakeholders.
- Draft, update, and gap‑analyse SOPs, guidelines, and training handbooks.
- Lead interactions with IT/RDIT for system issue resolution and future enhancements.
- Raise and manage deviations, vendor/customer complaints, and associated CAPA activities.
- Support clinical development teams on outsourced IRT studies, providing technical guidance.
- Participate in help‑desk rotations (daytime, nights, weekends, holidays) and act as point of contact for complex queries from study nurses, pharmacists, and other staff.
**Required Skills:**
- Strong expertise in IRT configuration, randomization, blinding/un‑blinding, and study lifecycle management.
- Excellent analytical skills with ability to interpret data and drive process improvements.
- Proven experience in clinical supply chain concepts and inventory management.
- Strong written and verbal communication; ability to produce SOPs, training materials, and eTMF documentation.
- Ability to work autonomously, prioritize multiple studies, and meet tight timelines.
- Experience interfacing with cross‑functional teams (statisticians, supply managers, study managers, safety, medical leads).
- Familiarity with regulatory requirements for clinical trial systems (GCP, 21 CFR Part 11).
**Required Education & Certifications:**
- Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field (Master’s preferred).
- Professional certification in clinical research or supply chain (e.g., ACRP, ASQ) is a plus.
- Minimum 3–5 years of experience in IRT support within clinical trial environments.