Director, EDC Programming

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🕒 6 dias atrás

🌐 Estados Unidos, Reino Unido – Remoto

🇺🇸 Estados Unidos – Remoto (EUA) 🇬🇧 Reino Unido – Remoto (RU)

🔔 Pennsylvania – Remoto

🔔 Pennsylvania – Remote

💵 $192.000 - $288.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Jazz Pharmaceuticals

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2003

🏥 Saúde

🏭 Manufatura

🧬 Biotecnologia

Healthcare • Manufacturing • Biotechnology

A Jazz Pharmaceuticals é uma empresa biofarmacêutica dedicada ao desenvolvimento de medicamentos inovadores que atendem a necessidades médicas não atendidas. Com um forte compromisso com pesquisa e desenvolvimento, a Jazz foca em criar terapias que transformam vidas, enfatizando a importância da colaboração, diversidade e engajamento dos funcionários em suas operações. A empresa se orgulha de transformar a vida dos pacientes por meio de suas ofertas de produtos significativas e uma cultura que promove entusiasmo e flexibilidade.

Descrição

• Provide leadership, structure, and strategy for the EDC business segment • Serve as Business Process Owner for Jazz Medidata URL, Veeva CDMS, IRT, and eCOA • Lead strategic plans and objectives for EDC and data capture systems • Oversee development and improvements to Medidata Rave, Veeva CDMS, IRT, and eCOA core configurations • Manage vendor relationships, URL risk assessments, enhancements, performance monitoring, and troubleshooting • Manage URL and Medidata Rave user/site administration, security, and study-level archival activities • Optimize EDC Programming resources and mentor assigned staff • Select, manage, and oversee EDC Programming CROs • Manage Medidata project management, business development, budgets, contracts, and invoices • Oversee Clinical Coding • Maintain and develop EDC standards, Global Library specifications, eCRFs, edit checks, custom functions, and EDC reporting • Support data standards implementation, technical quality, system compliance, CDISC alignment, and regulatory guidance • Partner with clinical data managers and study teams on EDC builds and migrations • Serve on the Clinical Data Operations Leadership Team and Data Standards Committee • Liaise with Clinical Data Factory, Clinical Insights, IT, Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management, and Regulatory teams • Develop EDC reports, data capture technologies, operational plans, SOPs, work practices, and manuals • Oversee Rave Safety Gateway, including script specifications, setup, repointing, and validation • Support regulatory submissions and inspections as an EDC subject matter expert • Maintain EDC Programming documentation for the TMF and regulatory submissions

🎯 Requisitos

• Minimum of a bachelor’s degree in computer science or a science-related discipline • Extensive pharmaceutical/CRO experience in an FDA-regulated environment • Demonstrated experience using Medidata Rave from front-end data management and back-end user perspectives • Experience leading an EDC programming team • Advanced experience using SAS and SQL, Crystal Reports, Business Objects, and other business intelligence tools • Thorough knowledge of EDC programming, including EDC, IRT, and eCOA • Experience in all stages of a clinical trial and vendor oversight • Experience managing and mentoring EDC programmers • Knowledge of ICH/GCP guidelines as they relate to data management • Understanding of CDISC CDASH and SDTM standards • Extensive experience managing Medidata and other EDC data vendors • Extensive experience programming EDC databases, CRF design, query resolution, data validation, data integration, data coding, targeted SDV, and RSG setup/maintenance • Advanced knowledge of EDC systems, data structures, and integrations • Understanding of Clinical Coding requirements within clinical studies • Experience working with globally distributed teams • Experience representing EDC Programming in regulatory and/or internal inspections preferred • Travel may be required

🏖️ Benefícios

• Discretionary annual cash bonus or incentive compensation • Discretionary equity grants • Medical insurance • Dental insurance • Vision insurance • 401k retirement savings plan • Flexible paid vacation • Remote work arrangement

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