Clinical Programmer

🕒 Março 28

🐎 Kentucky – Remoto

🐎 Kentucky – Remote

⏰ Tempo Integral

🟢 Júnior

🖥 Engenheiro de Software

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CTI Clinical Trial and Consulting Services

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1999

🧬 Biotecnologia

💊 Farmacêutico

Biotechnology • Pharmaceuticals

CTI Clinical Trial and Consulting Services é uma organização de pesquisa por contrato (CRO) de serviço completo que fornece execução de ensaios clínicos, estratégia regulatória, serviços de laboratório e bioanalíticos, geração de evidências do mundo real e gestão de centros de pesquisa para patrocinadores de biotecnologia e farmacêuticos. Com expertise em estudos de Fase I a IV e áreas terapêuticas complexas (incluindo doenças raras, terapia celular e gênica, oncologia, neurologia e transplante), a CTI apoia o desenho de estudos, gestão de sites, recrutamento de pacientes, monitoramento, segurança/farmacovigilância, biometria e garantia de qualidade. Com sede em Covington, KY, a empresa enfatiza abordagens integradas e centradas no paciente e orientação regulatória global para acelerar o desenvolvimento e levar terapias aos pacientes.

Descrição

• Act as a primary database architect for client clinical databases using Medidata Rave, OmniComm TrialMaster, or other database applications as needed for Clinical Trials • Create database entry screens based on approved case report form (CRF) casebook • Perform internal testing of entry screens prior to user acceptance testing • Work with lead CP or Study Clinical Data Manager to implement system edits on built entry screens • Program validation procedures, in conjunction with the Sr. CP or CP II, for clinical studies and other billable projects. • Maintain necessary study build documentation as required by CTI SOPs • Meet all project deadlines on time and on budget • Ensure accuracy of clinical databases as compared to the CRF; perform user acceptance testing (UAT) of database and provide feedback to study team regarding any discrepancies • Perform UAT on programmed edits in the clinical database; ensure accuracy of edits in database as compared to edit specifications documents; provide feedback to study team on functioning of edits. • Perform review and issue queries for CRF data, based on automated edit checks, manual review, post-hoc data listings, and sponsor requirements • Maintain all necessary data review documentation to support accurate data cleaning.

🎯 Requisitos

• Bachelor’s degree or equivalent experience in Computer Science/Information Technology or a technical degree in a related field • 1+ years of experience working with databases in a complex clinical data management (CDM) environment, and/or equivalent combination of education and experience • Database experience with OmniComm TrialMaster or Medidata Rave is preferred

🏖️ Benefícios

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. • We also value ongoing education and training through tuition reimbursement and a dedicated training department. • Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. • We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. • We also encourage care for the world around us through our unique CTI Cares program.