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Conduct site visits and assessments to inspect IA plans and security control implementations and support Incident Response Team (IRT) activities. Experience with MS Active Directory, Splunk, ACAS/Nessus, McAfee, Windows, Linux, AWS Security, etc.
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Nice to Have 2+ years of RTSM/IRT experience. Nice to Have 2+ years of RTSM/IRT experience. Requirements Experience and expertise in coding in C#, ASP.NET framework, XML, HTML, CSS, and JavaScript.
$75,000 - $150,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Knowledge base includes solid experience and understanding of end-to-end clinical supply chain activities, systems knowledge (IRT, forecasting, planning, and simulation), and supplier management systems and strategy.
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Work as part of a team reviewing and assessing Risk Management Framework (RMF) authorization body of evidence for classified information systems, to include: System Security Plan (SSP), Security Control Traceability Matrix (SCTM), Continuous Monitoring Plan, Incident Response Plan, Access Control Plan, Security Assessment Plan, etc.
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Configure other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system.
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0-5 years experience in application development and/or the IRT industry. 0-5 years experience in application development and/or the IRT industry. Serve as the principal source through which requirements flow between project/product management, systems development, software testing, the user community and other stakeholders.
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Extensive experience in clinical supply management including logistics (labeling, packaging, distribution, expiries), inventory tracking, and managing IRT systems. Manage end to end supply chain activities including accountability and reconciliation for global trials for both IRT and non-IRT trials.
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Interfacing and escalating with various levels of cutomer NOS, MRT, IRT personnel to jointly troubleshoot. All work is performed inside enclave located on an active military base, no Travel is required.
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Experience/knowledge in forecasting, demand / supply planning , IRT systems, experience/knowledge in forecasting, demand / supply planning , IRT systems, responsibilities including but not limited to protocol interpretation, demand planning, supply planning, distribution.
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Knowledge of Clinical Trial Systems (EDC, IRT, CTMS), Good Clinical Practice and related industry regulations. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production.
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Information Systems Security Engineer Position Description CGI Federal is looking for an Information Systems Security Engineer for an exciting program in Chantilly, VA. This position requires a TS/SCI with CI polygraph clearance.
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Hands-on experience with at least one EDC system (e.g.: Medidata Rave, Inform, Veeva etc.,) Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents. Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint.
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Work as part of a cross-functional project team responsible for the delivery of Interactive Response Technology (IRT) for randomization and drug supply management in clinical trials. Designing the IRT solution to meet the study requirements based on the clinical protocol, Suvoda proposal and discussions with the client.
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Prepare, test and implement post production changes as per study needs while ensuring data integrity. The EDC Engineer will work with Data Management and Standards teams to implement new processes as well as enhance existing processes for efficiencies and compliance with Takeda Clinical trial builds.
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Work closely with University IT (UIT), Stanford Health Care (hospital) IT (SHC IT), Computer Resource Consulting Center (CRC), and School of Medicine IRT systems administrators to coordinate the maintenance, upgrade, and monitoring of servers / applications / interfaces that relate to patient medical records.
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