Clinical Database Programmer

🕒 il y a 10 jours

🌐 États-Unis, Brésil, +1 autres pays – Distant

🇺🇸 États-Unis – Télétravail 🇧🇷 Brésil – Télétravail 🇦🇷 Argentine – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🖥 Ingénieur Logiciel

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EDETEK Inc.

Site WebLinkedInTous les Emplois

201 - 500 employés

Fondée en 2009

💊 Pharmaceutique

🧬 Biotechnologie

☁️ SaaS

Pharmaceuticals • Biotechnology • SaaS

EDETEK Inc. est une entreprise d'informatique de développement clinique qui propose un écosystème cloud-natif pour la R&D et une plateforme eClinical intégrée pour soutenir les essais cliniques et les soumissions réglementaires. Son portefeuille de produits comprend les outils d'orchestration et de collaboration CONFORM™, une suite eClinical (CTMS, EDC, ePRO/eCOA, RTSM), des hubs d'intégration de données et de métadonnées, un lac de données cliniques et des environnements prêts pour le calcul statistique et les soumissions. EDETEK offre également des services – biostatistiques et programmation, gestion des données cliniques, développement d'études cliniques, rédaction médicale et opérations eClinical – ciblant les sponsors en pharmacie, biotechnologie et dispositifs médicaux. L'entreprise met l'accent sur l'interopérabilité, la qualité des données et les capacités activées par l'IA pour accélérer l'exécution des études et les soumissions réglementaires à l'échelle mondiale.

Description

• The eClinical / Medidata Database Programmer is responsible for building, configuring, testing, and maintaining clinical study databases and related eClinical system components. • Support clinical trial study startup, database build, edit check programming, system configuration, user acceptance testing, issue resolution, and production support. • Build and configure study databases in Medidata Rave or other eClinical platforms based on protocol, CRF specifications, data management plan, and sponsor requirements. • Configure electronic case report forms, visit schedules, fields, folders, matrices, forms, dynamics, derivations, and edit checks. • Support setup of study-specific workflows, roles, permissions, user groups, sites, countries, and access controls. • Configure standard and study-specific data entry rules, validation checks, and system behavior. • Support setup or configuration of coding dictionaries, external data transfers, lab data, eCOA/ePRO, RTSM/IWRS, or other integrated systems. • Develop and maintain edit checks, derivations, dynamics, and custom functions according to approved specifications. • Review edit check specifications and provide technical input to ensure checks are clear, accurate, and programmable. • Perform unit testing and support independent validation of database configuration and edit checks. • Resolve database build defects identified during testing, UAT, or production use. • Maintain documentation of build changes, testing evidence, and issue resolution. • Review clinical protocol and CRF design requirements. • Support development or review of CRF specifications, edit check specifications, and data validation specifications. • Identify inconsistencies among protocol requirements, CRFs, edit checks, and database configuration. • Collaborate with data managers, clinical teams, programmers, vendors, and sponsors to clarify requirements. • Support user acceptance testing, including test script development, test execution, defect tracking, and resolution. • Assist study teams with database-related questions during study startup, conduct, and closeout. • Troubleshoot production database issues and implement approved changes through change control. • Support mid-study updates, amendments, migration activities, and post-production database changes. • Ensure all database changes are properly documented, tested, reviewed, and approved. • Follow applicable SOPs, work instructions, validation procedures, and study-specific requirements. • Ensure database build activities comply with GCP, 21 CFR Part 11, audit trail expectations, and applicable regulatory requirements. • Maintain clear documentation for system configuration, testing, validation, and change control. • Support audits, inspections, and sponsor requests related to database build and eClinical system configuration.

🎯 Exigences

• Bachelor’s degree in life sciences, computer science, information systems, statistics, data management, or a related field. • Hands-on experience building clinical study databases in Medidata Rave, Rave EDC, or similar eClinical systems. • Experience with CRF design, edit check programming, database testing, and UAT support. • Good understanding of clinical trial processes and clinical data management activities. • Familiarity with GCP, 21 CFR Part 11, and computerized system validation principles. • Strong attention to detail and ability to follow specifications and controlled processes. • Good communication skills and ability to work with data management, clinical operations, programming, QA, vendors, and sponsor teams. • Medidata Rave database build experience, including Architect, Designer, Coder, Custom Functions, Amendment Manager, or related modules (Preferred). • Experience with multiple therapeutic areas and global clinical trials (Preferred). • Experience supporting Phase I to Phase III studies (Preferred). • Experience with external data integration, lab data, ePRO/eCOA, RTSM/IWRS, safety systems, or central monitoring systems (Preferred). • Experience with CDISC SDTM concepts or downstream data mapping requirements (Preferred). • Experience supporting audits, database validation, or study migration activities (Preferred). • Experience working in a CRO, pharmaceutical, biotech, or clinical technology environment (Preferred).

🏖️ Avantages

• Choice of comprehensive Medical, Vision and Dental Insurance plans • Paid vacation time and sick days • Corporate holidays annually • Participation in the 401K Plan • Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc. • Health Advocate and Employee Assistance Program