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IRT Design Lead
3 months ago
IRT Design Lead / Leader en conception – Technologie de réponse interactive (TRI) page is loaded
IRT Design Lead / Leader en conception – Technologie de réponse interactive (TRI) Apply locations Canada - Ontario - Mississauga time type Full time posted on Posted Yesterday job requisition idPosting 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.
For this position candidates will need to have excellent technical and analytical thinking skills, be a creative problem solver, and have a strong commitment to quality to successfully deliver optimal IRT systems across a diverse and dynamic portfolio.
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
The ideal candidate possesses the following qualifications:
- 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 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 solutions de TRI autant à l'interne et qu'avec nos fournisseurs externes. En tant que membre d'une chaîne d'approvisionnement clinique innovante, nous remettons régulièrement en question le statu quo afin d'optimiser nos systèmes et nos processus.
RÉSUMÉ DU POSTE
Le ou la leader en conception – TRI est responsable, au sein de son équipe, de la conception, de la configuration et de la vérification des études dans les systèmes internes de TRI de Pfizer. La mise en place de ce poste au sein de l'équipe mondiale de supervision en TRI a pour but d'assurer la fourniture de systèmes de TRI de haute qualité grâce à une expertise ciblée des systèmes, tout en améliorant la rapidité d'exécution afin de soutenir la gamme de produits en constante évolution de Pfizer.
Le ou la titulaire de ce poste sera affecté·e à l'étape d'élaboration des exigences et travaillera en étroite collaboration avec l'équipe mondiale de supervision en TRI, notamment ses leaders et son équipe de soutien, ainsi que l'équipe numérique de Pfizer (Technologies d'affaires) et l'Assurance de la qualité afin de s'assurer que les exigences, les normes, la conception et les livrables en matière de validation des systèmes sont utilisés de façon cohérente dans tous les programmes tout en respectant les échéanciers et les exigences de la gamme de produits.
Le ou la leader en conception – TRI travaillera également avec la direction de l'équipe mondiale de supervision en TRI sur des enquêtes de qualité, les engagements en matière de mesures préventives et mesures correctives, les améliorations continues, et les activités d'examen et de révision des modes opératoires normalisés, ainsi qu'avec d'autres équipes à mandat limité, le cas échéant.
Pour occuper ce poste, les candidats et candidates devront posséder d'excellentes compétences techniques et analytiques, faire preuve de créativité dans la résolution des problèmes et faire montre d'un solide engagement envers la qualité afin de pouvoir proposer des systèmes de TRI optimaux pour une gamme de produits diversifiée et dynamique.
FONCTIONS DU POSTE
- Concevoir, configurer et tester les systèmes internes de TRI à l'aide de la documentation relative aux exigences fournie par les leaders – TRI, tout en veillant à ce que les normes de configuration soient intégrées dans la construction des systèmes.
- Gérer les plans de livraison pour les activités liées à la configuration et aux tests, et communiquer les risques.
- Collaborer avec le ou la leader – TRI concerné·e pour définir la stratégie de test et avec l'équipe numérique de Pfizer pour élaborer et déployer la logique propre aux études, le cas échéant, afin de soutenir les plans d'études complexes.
- Créer des documents de soutien sur la TRI et faire une démonstration du système à l'équipe de l'étude dans le cadre du processus de validation du système.
- Rédiger et approuver les tests d'acceptation par l'utilisateur et les résumés pour les études assignées où ces tests sont employés; repérer les anomalies et contribuer à leur résolution.
- Effectuer des contrôles de qualité pour chaque configuration se rapportant à la TRI de l'étude.
- Soutenir les enquêtes sur la qualité et les projets d'amélioration continue, et contribuer à l'élaboration de modes opératoires normalisés et de processus.
Le candidat idéal possède les qualifications suivantes :
- B.A. ou B. Sc. en sciences informatiques, en sciences ou dans le domaine des affaires, de préférence dans l'industrie biopharmaceutique.
- Au moins 5 ans d'expérience avec les systèmes de TRI sont requis; de préférence, expérience en configuration et validation de systèmes de TRI.
- Compréhension de la nature des données cliniques, avec une considération particulière pour les concepts de configuration de l'étude en TRI, les paramètres de réapprovisionnement, la mise à l'insu, la protection de la vie privée ainsi que les normes de qualité et d'intégrité des données.
- Expérience avec les outils de comparaison de Microsoft tels que Word Compare et Excel Exact Match.
- Expérience de la méthodologie de développement « souple » de préférence, y compris l'utilisation de scénarimage et de cas de test associés.
- Expérience de travail dans un environnement soumis aux bonnes pratiques de fabrication / bonnes pratiques cliniques et avec des équipes de vérification réglementaire.
- Excellente maîtrise de l'anglais, tant à l'oral qu'à l'écrit, souhaitée.
- À l'aise dans un environnement changeant et dynamique, avec une équipe internationale, des partenaires ainsi que des client·e·s.
APTITUDES PHYSIQUES OU MENTALES
- Compétences en matière de recherche dans les bases de données, d'analyse commerciale et de rédaction technique, un atout.
- Expérience souhaitée dans l'analyse des causes principales à l'aide d'outils tels que les analyses des modes de défaillance et de leurs effets (AMDE), la méthode des 5 Pourquoi, la matrice de causes et effets (diagramme en arêtes de poisson).
Nous sommes fiers d'offrir à nos employés un modèle de travail flexible qui leur permet de planifier leurs journées afin de maximiser leur productivité, d'atteindre un meilleur équilibre entre leur vie personnelle et leur vie professionnelle et de favoriser une nouvelle façon de travailler, qui sera centrée sur les patients et stimulera l'innovation. Actuellement, nos employés sont tenus de travailler sur place 2.5 à 3 jours par semaine, en combinant la collaboration et la communication en présentiel et le télétravail, lorsque cela est approprié pour l'entreprise.
At Pfizer, we embrace diversity and inclusion for innovation and growth. We are committed to building inclusive teams and an equitable workplace for our employees to bring their true selves to work.
We also strive to provide an accessible candidate experience for our prospective employees with different abilities. Please let us know if you need any accommodations during the recruitment process.
Chez Pfizer, nous accueillons la diversité et l'inclusion pour stimuler l'innovation et la croissance. Nous sommes déterminés à créer des équipes inclusives et un milieu de travail équitable pour que nos employés puissent exprimer leur vraie personnalité au travail.
Nous nous efforçons également d'offrir une expérience de candidature accessible à nos employés potentiels ayant des habiletés différentes. N'hésitez pas à nous faire savoir si vous avez besoin de mesures d'adaptation au cours du processus de recrutement.
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