Director, EDC Programming

Emploi pas sur LinkedIn

🕒 il y a 3 jours

🌐 États-Unis, Royaume-Uni – Distant

🇺🇸 États-Unis – Télétravail 🇬🇧 Royaume-Uni – Télétravail

🔔 Pennsylvania – Distant

🔔 Pennsylvania – Remote

💵 $192 000 - $288 000 / an

⏰ Temps Plein

🔴 Expert

👔 Directeur

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 0%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Jazz Pharmaceuticals

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 2003

🏥 Santé

🏭 Fabrication

🧬 Biotechnologie

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals est une entreprise biopharmaceutique dédiée au développement de médicaments innovants répondant à des besoins médicaux sérieux non satisfaits. Avec un fort engagement envers la recherche et le développement, Jazz se concentre sur la création de thérapies transformatrices, mettant en avant l'importance de la collaboration, de la diversité et de l'engagement des employés dans ses opérations. L'entreprise est fière de transformer la vie des patients grâce à ses offres de produits significatives et une culture qui favorise l'enthousiasme et la flexibilité.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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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