Clinical Study Build Programmer

🕒 Setembro 25

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $79.500 - $169.400 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🖥 Engenheiro de Software

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Eli Lilly and Company

SiteLinkedInTodas as Vagas

10.000+ funcionários

💊 Farmacêutico

🏥 Saúde

🧬 Biotecnologia

💰 $6.500.000 Post-IPO Debt - Eli Lilly em 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company é uma empresa farmacêutica multinacional que pesquisa, desenvolve, fabrica e comercializa medicamentos de prescrição em várias áreas terapêuticas, incluindo diabetes, oncologia, imunologia, neurociência e dor. Com sede em Indianápolis, Indiana, Lilly é conhecida por sua extensa P&D, desenvolvimento clínico e comercialização global de medicamentos biológicos e de pequenas moléculas. A empresa foca na descoberta de medicamentos, ensaios clínicos, aprovações regulatórias e fabricação e distribuição farmacêutica em larga escala.

Descrição

• Program and test clinical trial data collection databases, including mapping, testing, and normalization into a clinical data warehouse • Configure clinical data collection systems such as eCOA/EDC platforms • Build study forms, logic, edit checks, workflows, integrations, and data repository mappings • Gather and influence eCOA design specifications and support implementation • Understand study translation needs and enable localization • Deliver accurate data collection systems and data warehouse mappings aligned with study objectives • Provide insights into study design and data delivery, including the Data Management Plan, Project Plan, database, and observed datasets • Support submission, inspection, and regulatory response activities • Lead complex cross-Business Unit/Therapeutic Area projects or programs • Develop and test innovative solutions • Improve development speed, accuracy, consistency, and study build cycle time • Enable metrics reporting for study development timelines and database changes • Partner with Data and Analytics colleagues to deliver study databases before first patient visit • Influence data standard decisions and strategies • Apply regulatory and privacy requirements to study database building • Integrate multifunctional, external, and technical information for data-driven decisions • Reduce postproduction changes through change-control processes • Anticipate and resolve technical, operational, and business problems affecting Data and Analytics • Manage delivery risks and define database solutions and timelines for the portfolio

🎯 Requisitos

• Master’s degree in a scientific field such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, or Computer Sciences, plus 3 years of related experience • Alternatively, bachelor’s degree plus 5 or more years of experience in clinical data management or closely intersecting areas • Experience with designing and handling eCOA data • Ability to articulate data flow from patient to analysis and apply this knowledge to data solutions • Experience deciding technology platforms for data acquisition and aggregation • Clinical/drug development knowledge and ability to liaise with study team members • Strong therapeutic/scientific knowledge in the research field • Familiarity with clinical data tools and technologies • Understanding and experience using data standards • Ability to balance multiple activities, prioritize, and manage ambiguity • Domestic and international travel may be required • Knowledge of applicable internal, external, and regulatory requirements/expectations, including MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, and privacy requirements

🏖️ Benefícios

• Company bonus depending partly on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and prescription drug benefits • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities • Employee resource groups offering support networks