Project Manager in Irt - Montréal, Canada - Keyrus Life Science North America
Description
Keyrus Life Science is looking for aProject Manager in IRT to join our consulting team based in
Canada.
Position fully dedicated to GSK global team.
IRT stands for Interactive Response Technology. Another term that has been used to describe this technology is '
randomization and trial supply management'. Essentially, IRT helps clinical trial sponsors and sites manage the patient and drug supply logistics throughout a clinical trial.
Because of its ability to offer control and flexibility while increasing efficiency, it has served a vital role in helping our client organize data to mitigate risk and to reduce time and costs in their trials.
Your challenges 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 stockouts, 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, holidays).
- Responsible for drafting, amending, & 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 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. - Expected 36 months training and support prior to first study configuration, depending on prior knowledge of IRT configuration.
Profile
- Minimum of 57 years related experience in IRT or clinical supplies required.
- Scientific degree or equivalent experience required.
What we offer
At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program.
international environment with enthusiastic and professional colleagues.
We invest considerable time and resources in
training our staff (technical and non-technical courses) to support you in your continuous personal and professional growth.
On top of this, you will receive a complete salary package including attractive extra-legal benefits ( pension and health insurance,) based on your background and experience.
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
human approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Life Science we're proud of our commitment to deliver services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients' projects, priorities and reputation.
Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better.
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
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