Website Alsinova
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
Alsinova
Alsinova is setting new standards for CROs by integrating multidisciplinary expertise with advanced technology. Alsinova offers a complete CRO solution, providing innovative, customised solutions in various life science segments: pharmaceuticals, biotechnology, medical devices, cosmetics, agri-food, veterinary and healthcare institutions.
Alsinova is the subsidiary of the Astek Group, a global player in engineering and technology consulting. Since its creation, the Group has based its development on a strong culture of entrepreneurship and innovation, and on the support and skills development of its 10.000 employees who are committed every day to promoting combination of digital technologies and complex systems engineering.
Join a Group rapidly developing in France and around the world, with a turnover of 705 M€ in 2024.
More on the Group on our websites https://alsinova.com and https://astek.net.
Astek is committed to the employment of people with disabilities.
Our benefits
Joining Astek means choosing:
- an experience accelerator, where every assignment is an opportunity to progress
- access to a multitude of technically exciting projects for our clients as well as internally
- individualized, local support for a tailored career path
- continuous learning, thanks to our internal training academy
- a friendly and inclusive work environment, supported by #TopEmployer2025 certified HR practices
Let’s move forward.