Clinical Database Designer I

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🕒 vor 2 Monaten

🌐 Vereinigte Staaten, Kanada – Remote

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🏖️ New Jersey – Remote

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💵 $50.000 - $90.000 / Jahr

⏰ Vollzeit

🟢 Junior

✍️ Designer

🦅 H1B-Visum-Sponsor

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🗣️🇺🇸🇬🇧 Englisch erforderlich

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Logo of Everest Clinical Research

Everest Clinical Research

501 - 1000 Mitarbeiter

Gegründet 2004

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

Healthcare • Consulting • Logistics

Everest Clinical Research ist eine globale Clinical Research Organization (CRO), die umfassende Dienstleistungen im Bereich klinische Studien und Biometrics-Expertise für Pharma- und Biotechnologie-Sponsoren bietet. Das Unternehmen offeriert klinische Operationen und Projektmanagement, risikobasiertes Qualitätsmanagement und zentralisiertes Monitoring, medizinisches Monitoring, Pharmakovigilanz, klinisches Datenmanagement, Biostatistik und statistische Programmierung, regulatorische Strategie und Einreichungen sowie Technologielösungen wie IRT/RTSM und ePRO/eCOA. Everest positioniert sich als ein qualitativ hochwertiger Partner mit globaler Reichweite und therapeutischer Expertise in den Bereichen Onkologie, Neurologie, Atemwegserkrankungen, seltene Krankheiten und Immunologie.

Beschreibung

• Design clinical database for new studies based on requirement specifications in various electronic data capture (EDC) systems • Perform post go-live changes (database modifications) based on updated requirement specifications in various electronic data capture (EDC) systems and provide impact assessment for modifications • Perform Unit Testing on database design, assist User Acceptance Test (UAT) activities, and address UAT findings • Set up and configure the development environment for new studies • Assist the creation of the Database Integration Specification (DIS) with other systems, provide Integration Technical Detail (ITD) as needed, program the integration, and assist the integration test • Support the Data Manager in investigating and addressing issues related to the database design • Review study design requirement specifications for assigned projects, ensuring the specifications adhere to EDC platform standards and Everest Standards • Maintain database design timelines and promote good project management practices • Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design by reading, participating in relevant training, and/or associated activities • Validate and disseminate real-time study monitoring reports to Sponsor and internal team members.

🎯 Anforderungen

• B.Sc. in Biological Sciences or Computer Science • One year clinical database design experience, such as developing clinical databases in DFdiscover, InForm, Medidata Rave, Clinical One, and/or other EDC systems • Software programming experience relevant to the programming languages and design applications in use in clinical research • Must communicate effectively, orally and in writing, with personnel on all professional and administrative levels • Excellent interpersonal skills in complex team situations, including the ability to build relationships with both internal and external clients • Demonstrated ability to effectively organize and integrate the activities of information processing personnel • Must be well-organized and able to work independently and manage multiple projects/tasks appropriately.

🏖️ Vorteile

• medical, dental, and vision coverage • life & AD&D insurance • short- and long-term disability • tuition reimbursement • fitness reimbursement • employee assistance program (EAP) • 401(k) retirement • generous paid time off and sick leave • opportunity to earn a performance based bonus

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