IRT Specialist in Clinical Supply Chain - Montréal, Canada (F / M)

ALSINOVA CRO; Montreal; On-site; CAD 60,000 - 80,000; Full time

Job summary

Join ALSINOVA CRO as an IRT Specialist in Clinical Supply Chain in Montreal. You will be responsible for managing complex IRT study designs, ensuring quality processes, and supporting clinical study operations. This full-time, entry-level role offers competitive pay and opportunities for professional development within a leading company in the clinical research sector.

Qualifications

• Entry-level position requiring analytical skills and ability to manage study designs.
• Proven capability in process improvements and communication skills.

Responsibilities

• Configure and manage complex IRT study designs independently.
• Develop supply strategy, identify issues, and implement solutions.
• Provide technical support to Clinical Development for outsourced IRT studies.

Skills

Data Analysis

Problem Solving

Process Improvement

Job description

Join to apply for the IRT Specialist in Clinical Supply Chain - Montréal, Canada (F / M) role at ALSINOVA CRO

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Join to apply for the IRT Specialist in Clinical Supply Chain - Montréal, Canada (F / M) role at ALSINOVA CRO

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 answer 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., 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)

Your Daily Activities Will Be

• Independently configure and manage / maintain 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.
• Identify, own, and implement process improvements and training needs & gaps.
• Analyse data and drive / implement continuous improvements.
• Provide technical guidance / support to Clinical Development for their outsourced IRT studies.
• Lead interactions with RDIT for operational system issues and drive future IRT enhancements.
• Raise Deviations / Vendor Complaints / Customer Complaints and associated CAPAs. Manage and lead interactions with study statisticians, Clinical Trial Supply Managers, Study Managers, Clinical Research Development Leads / Medical Lead, Safety, Helpdesk, and Tech teams.
• IRT Specialist in Clinical Supply Chain

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Management and Manufacturing
• Health and Human Services

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