IRT Specialist in Clinical Supply Chain - Montréal, Canada (F/M)
About the role
What We Will Accomplish Together Alsinova is looking for a IRT Specialist in Clinical Supply Chain .
Your Mission (should You Decide To Accept It) Study Set up and maintenance (e.g., creating, amending study in IRT based on protocol design, amendments, helping answering Helpdesk, central and local study teams on complex IRT questions/study operational situations on a day-to-day basis) Quality and processes (e.g., creating/updating SOP, guidelines, training materials, handbooks, delivering F2F IRT trainings to study stat, safety etc., responsible for all IRT related study documentation in eTMF from creation to archiving stage, regularization of legacy/non-documented processes) Supporting Study team as overall SME for IRT tool, randomization, blinding/un-blinding (e.g., continuously supporting study statisticians, trial supply managers and other central functions from concept protocol design to logistical & supply strategy design to protocol amendment, study operational manual, providing inputs to quality incidents /CAPAs, FSO study setup, attending IT meetings as IRT business owner pushing on improvements, bug-fixes, informal testing etc.
Your Daily Activities Will Be
- Independently configures and manages/maintains complex IRT study designs, possibly those with an international or more complex design, adaptive design, etc.
- Proactively identify and communicate issues as well as provide proposed solutions.
- Develop supply strategy to eliminate stock outs, minimize waste and reduce shipments.
- Assist with Helpdesk during daytime hours, when needed, in addition to participating on Helpdesk Stand-by/On-Call rotations (nights, weekends, and holidays).
- Responsible for drafting, mending, & determining gaps in SOPs.
- Accountable for identifying, owning, and implementing process improvements and training needs & gaps.
- Analyse data and drive/implement continuous improvements.
- Provide technical guidance/support to Clinical evelopment for their outsourced IRT studies.
- Lead interactions with RDIT for operational system issues and drive future IRT nhancements.
- Raise Deviations/Vendor Complaints/Customer Complaints and associated CAPAs. Manage and lead interactions with:
- Study statisticians
- Clinical Trial Supply Managers and Trial supply assistants
- Study Managers (Study Delivery Leads, Local Delivery Leads) and Study Monitors
- Clinical Research Development Leads/Medical Lead, Safety
- Helpdesk (sometimes can directly answer to study nurse, pharmacist for a complex question)
- Tech
You
- IRT Specialist in Clinical Supply Chain
Our Benefits Rejoindre Astek, c'est choisir :
- un accélérateur d’expérience, où chaque mission est une opportunité de progresser
- un accès à une multitude de projets techniquement passionnants pour nos clients comme en interne
- un accompagnement de proximité individualisé pour un parcours professionnel sur mesure
- un apprentissage continu, grâce à notre Académie de formation interne
- un environnement de travail convivial et inclusif, soutenu par des pratiques RH certifiées #TopEmployer2025 Let's move forward.
About ALSINOVA CRO
Alsinova, a subsidiary of Astek, is redefining Non Clinical & Clinical Research. ° With our Digital CRO approach, we merge medical expertise and cutting-edge technology to deliver unified, end-to-end solutions across 26 countries.
Non Clinical & Clinical Research, RWE, Regulatory Affairs, Vigilance… ° We support our clients throughout the lifecycle—from R&D to market access with deep expertise in data science, AI, automation & machine learning
Global reach, Local expertise ° Our flexible collaboration models and worldwide presence ensure proximity and agility.
More than tools, true partnership ° We empower clients by combining people and AI-driven technologies to create tailored, reliable, and sustainable solutions.
IRT Specialist in Clinical Supply Chain - Montréal, Canada (F/M)
About the role
What We Will Accomplish Together Alsinova is looking for a IRT Specialist in Clinical Supply Chain .
Your Mission (should You Decide To Accept It) Study Set up and maintenance (e.g., creating, amending study in IRT based on protocol design, amendments, helping answering Helpdesk, central and local study teams on complex IRT questions/study operational situations on a day-to-day basis) Quality and processes (e.g., creating/updating SOP, guidelines, training materials, handbooks, delivering F2F IRT trainings to study stat, safety etc., responsible for all IRT related study documentation in eTMF from creation to archiving stage, regularization of legacy/non-documented processes) Supporting Study team as overall SME for IRT tool, randomization, blinding/un-blinding (e.g., continuously supporting study statisticians, trial supply managers and other central functions from concept protocol design to logistical & supply strategy design to protocol amendment, study operational manual, providing inputs to quality incidents /CAPAs, FSO study setup, attending IT meetings as IRT business owner pushing on improvements, bug-fixes, informal testing etc.
Your Daily Activities Will Be
- Independently configures and manages/maintains complex IRT study designs, possibly those with an international or more complex design, adaptive design, etc.
- Proactively identify and communicate issues as well as provide proposed solutions.
- Develop supply strategy to eliminate stock outs, minimize waste and reduce shipments.
- Assist with Helpdesk during daytime hours, when needed, in addition to participating on Helpdesk Stand-by/On-Call rotations (nights, weekends, and holidays).
- Responsible for drafting, mending, & determining gaps in SOPs.
- Accountable for identifying, owning, and implementing process improvements and training needs & gaps.
- Analyse data and drive/implement continuous improvements.
- Provide technical guidance/support to Clinical evelopment for their outsourced IRT studies.
- Lead interactions with RDIT for operational system issues and drive future IRT nhancements.
- Raise Deviations/Vendor Complaints/Customer Complaints and associated CAPAs. Manage and lead interactions with:
- Study statisticians
- Clinical Trial Supply Managers and Trial supply assistants
- Study Managers (Study Delivery Leads, Local Delivery Leads) and Study Monitors
- Clinical Research Development Leads/Medical Lead, Safety
- Helpdesk (sometimes can directly answer to study nurse, pharmacist for a complex question)
- Tech
You
- IRT Specialist in Clinical Supply Chain
Our Benefits Rejoindre Astek, c'est choisir :
- un accélérateur d’expérience, où chaque mission est une opportunité de progresser
- un accès à une multitude de projets techniquement passionnants pour nos clients comme en interne
- un accompagnement de proximité individualisé pour un parcours professionnel sur mesure
- un apprentissage continu, grâce à notre Académie de formation interne
- un environnement de travail convivial et inclusif, soutenu par des pratiques RH certifiées #TopEmployer2025 Let's move forward.
About ALSINOVA CRO
Alsinova, a subsidiary of Astek, is redefining Non Clinical & Clinical Research. ° With our Digital CRO approach, we merge medical expertise and cutting-edge technology to deliver unified, end-to-end solutions across 26 countries.
Non Clinical & Clinical Research, RWE, Regulatory Affairs, Vigilance… ° We support our clients throughout the lifecycle—from R&D to market access with deep expertise in data science, AI, automation & machine learning
Global reach, Local expertise ° Our flexible collaboration models and worldwide presence ensure proximity and agility.
More than tools, true partnership ° We empower clients by combining people and AI-driven technologies to create tailored, reliable, and sustainable solutions.