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Irt Design Lead

4 months ago

Mississauga, Canada Pfizer Full time

Posting closing date: June 17th, 2024

Date de fin d’affichage : le 17 juin 2024

Status: Regular, Full-Time

Statut : Régulier, temps plein
- (Français ci-dessous)_

IRT Design Lead

The IRT Global Oversight Team (IGOT) is a well-established high performing team within Pfizer's Global Clinical Supply unit striving to deliver best in class Interactive Response Technology (IRT) systems providing randomization and drug management capabilities in support of Pfizer's dynamic investigational product portfolio. The patients we serve are our number one priority and IGOT aims to employ the highest quality standards across our internal and vendor IRT solutions. As part of an innovative clinical supply chain, we routinely challenge the status quo in efforts to optimize our systems and processes.

ROLE SUMMARY

The IRT Design Lead is a role within the Design team that is responsible for designing, configuring, and verifying study builds in Pfizer’s internal IRT systems. The implementation of this dedicated function within IGOT is intended to ensure the delivery of high quality IRT systems through focused system expertise while improving velocity in support of Pfizer’s evolving portfolio.

The IRT Design Lead will be assigned at the requirements elicitation stage and will partner closely with IGOT’s IRT Leads, IGOT’s Support Team, Pfizer Digital (Business Technology), and Quality Assurance to ensure system requirements, standards, design, and validation deliverables are consistently employed across programs while meeting portfolio timelines and demands.

The IRT Design Lead will also partner with IGOT management on quality investigations, CAPA commitments, continuous improvements, SOP review and revision activities, and other limited duration teams where appropriate.

ROLE RESPONSIBILITIES
- Design, configure and test internal IRT systems using requirements documentation supplied by IRT Leads while ensuring configuration standards are incorporated into system builds
- Manage the delivery plan for configuration and testing activities and communicate risks
- Partner with the IRT Lead to identify testing strategy and with Pfizer Digital to develop and deploy study specific logic (SSL) where needed to support complex study designs
- Create supportive IRT documents and provide a system demo to the study team as part of system acceptance process
- Write and approve user acceptance testing (UAT) and summaries for assigned studies where UAT methodology is employed; track defects and support resolution
- Perform quality checks (QC) for each study IRT configuration
- Support quality investigations and continuous improvement projects and provide input into SOPs and process development
- BA/BS, in computer science, scientific, or business field desired in biopharma industry
- Minimum 5+ years of experience with IRT systems required; IRT system configuration and validation experience preferred
- Understanding of the nature of clinical data, with particular regard to the concepts of IRT study configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards
- Experience with the use of Microsoft compare tools such as Word Compare and Excel Exact Match
- Experience with Agile development methodology preferred including use of storyboards and associated test cases
- Exposure to working in a GMP / GCP environment and with regulatory audit teams
- Strong English language, written and verbal communication desired
- Comfortable working with a global team, partners and customers in a change agile environment

PHYSICAL/MENTAL REQUIREMENTS
- Database query, business analysis and technical writing skills a plus
- Experience participating in root cause analysis using tools such as FMEA, 5-Why, Cause & Effect Matrix and/or Fish Bone diagram desired

We are proud to offer employees a flexible working model that is grounded on empowering colleagues to design their workdays so that they can maximize their productivity, enhance their work-life balance and support a way of working that fosters innovation and patient-centricity. Currently, our employees are expected to be on-site 2.5 - 3 days per week blending on-site collaboration and connection with off-site remote working when it makes business sense to do so.

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Leader en conception - Technologie de réponse interactive (TRI)

L’équipe mondiale de supervision en technologie de réponse interactive (TRI) est une équipe très performante et bien établie au sein de l’unité mondiale de l’Approvisionnement clinique de Pfizer qui a pour objectif de proposer les meilleurs systèmes de TRI qui offrent des capacités de répartition aléatoire et de gestion des médicaments pour soutenir la gamme de produits expérimentaux dynamique de Pfizer. Les patients et patientes que nous servons sont notre priorité absolue et l’équipe mondiale de supervision en TRI s’efforce d’appliquer les normes de qualité les plus élevées à nos solut