Interactive Response Technology Implementation Analyst

Summary The Global Clinical Supply (GCS) Interactive Response Technology (IRT) Implementation Analyst is a position within Global Central Operations Network (GCON) GCS Strategic Hubs (GSH) team and will be based in Costa Rica. The IRT Implementation Analyst will be reporting to the GSH Team Lead in Costa Rica, with a matrix reporting relationship to the Engagement Leader, IRT Global Oversight Team (IGOT) within Clinical Supply Informatics & Technology (CSIT).     GCS manages the execution of supply chain strategies to deliver Investigational Medicinal Product to patients involved in Pfizer’s clinical research trials across the globe.   IGOT is a well-established high performing team within Pfizer's GCS unit striving to deliver best in class 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.   The IRT Implementation Analyst is an individual contributor who performs defined implementation activities under the direction of an accountable IRT Lead, Design Lead, or functional lead. Responsibility and independence will expand progressively based on completion of required training, demonstrated proficiency, and role readiness.

The IRT Implementation Analyst is a new role within the IRT IGOT that will support requirements and system development.  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 Implementation Analyst will go through a robust onboarding and technical training period where they will partner closely with IGOT’s IRT Leads and Design Leads to develop proficiency in conducting preliminary protocol assessments, eliciting protocol requirements, and designing and configuring study builds on Pfizer’s internal IRT system. The IRT Implementation Analyst will support Implementation team members by organizing and facilitating meetings, capturing meeting minutes, creating and reviewing IRT supportive documents, and delivering investigator meeting slides to clinical teams and site personnel.  IRT Implementation Analysts will also support line leads in collaborating with study team and supply chain personnel to resolve issues, understand how study requirements are configured and supported post study go-live, and for ongoing studies, be available for guidance on IRT resupply settings and any requisite system amendments.   The IRT Implementation Analyst will also learn how quality investigations, Correction Action/ Preventive Action (CAPA) commitments and continuous improvements, Standard Operating Procedure (SOP) review and revision activities, support regulatory inspections, and limited duration teams are created and executed.   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. What You Will Achieve Support the delivery plan for IRT configuration and testing activities. Support the elicitation and documentation of system requirements for new and amended studies in partnership with the study team. Support the development and execution of User Acceptance Testing (UAT) test plans. Participate in cross line initiatives, quality investigations, SOP development, and process improvement. Will be trained to create IRT supportive documents and deliver investigator meeting slides to clinical teams and site personnel. Support for Assigned Projects: Aid in the design,