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Experience with implementing and maintaining infrastructure for Informatica tools like PIM/Product 360, IDQ, ActiveVOS, Media Manager, Axon, EDC, PowerExchange, PowerCenter and/ orany Informatica MDM or ETL products.
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Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). ICON plc is a world-leading healthcare intelligence and clinical research organization.
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Act as a SME on core business software solutions (e.g., RAVE EDC system) to provide novel end-to-end software solutions that improve, automate, and solve complex business process challenges. Lead the development of clinical study databases in the Rave EDC system according to the department SOPs, including programming complex Custom Functions in C.
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Good technical skills and ability to quickly learn new software; pre-intermediate MS Excel; preferred experience with Clinical Trial Management System (CTMS) and/or Site Payment platform, EDC and financial systems.
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This includes Source Data Validation (SDV) of clinical study data entered on the Case Report Forms (CRF) in the Electronic Data Capture (EDC) system, review and reconciliation of the Investigational Site File (ISF) with the Electronic Trial Master File (eTMF), ensure proper documentation of Investigational Product (IP), and ensure overall adherence to protocol procedures.
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Lead the On-Prem EDC, AXON, and IDQ Migration to Cloud Data Governance & CDQ. Lead the Data Program's platform Administration for Informatica EDC, AXON, IDQ, and Informatica Cloud IDMC platforms.
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Administration skills a plusAzure Cloud Technologies: Azure Data Factory, Azure Databricks, Azure Blob Storage, Azure Data Lake, Azure Power Apps and Azure FunctionsCI/CD: GitHub, Jenkins, Azure DevOps, TerraformBI Analytics Tool Stack - Cognos, Tableau, Power BI, Alteryx, Denodo, and GrafanaData Wehousing: DataStage, InformaticaData Governance and Privacy: Informatica Axon and EDC, BigID.
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This will include, but is not limited to: sponsor provided and IRB approved Protocol Training All relevant Protocol Amendments Training, any study specific Manuals Training as applicable Sponsor-specified EDC and/or IVRS Any other relevant Electronic Systems training.
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MUST have recent edc experience-Electronic Data Capture. This is a Clinical SYSTEMS PM - prior experience with the requirements and design of systems (e.g. Almac, Medidata) are required as the 2 spots will need to be able to triage and take ownership of the customization of the trial systems being implemented.
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Components that align to technologies supported at Southern Glazers. Any experience Installing and/ or Configuring Informatica tools PIM/Product 360, IDQ, ActiveVOS, Media Manager, etc. Experience in install, configure and maintain Informatica applications on Linux/Unix OS.
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Create/populate data lineage and linkage between the technical and business metadata, onboarding of technical and business metadata into the Informatica EDC and Axon. As part of the Data Strategy program, this Informatica Admin position supports Informatica Data Governance platform administration with primary a focus on setting up and administering EDC resource scanning discovery and profiling.
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5+ years of experience as an Admin extensively worked on Informatica EDC, Axon, IDQ. This opportunity is a Fulltime position as Informatica EDC On-Site Please have a look at the job description below and let me know if you or someone you know is interested in this role.
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Proficient in FDA, GCP, and ICH guidelines, with solid expertise in EDC systems, data management functions, and ideally, CDISC standards. Proficient in FDA, GCP, and ICH guidelines, with solid expertise in EDC systems, data management functions, and ideally, CDISC standards.
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Ensure oversight of all deliverables of activities outsourced to CROs as outlined in the SOW and described in the Data Management Trial Oversight plan, including, but not limited to:Creation of data collection tools (EDC, DTAs for 3rd party vendors, EDC integrations)Creation of essential documents (DMP, UAT documents)Creation of submission ready clinical data package per regulatory agencies requirementsCreation of archival package of clinical data per argenx requirements.
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Experience in VCM and/or EDC manufacturing technologies. 150k to 175k Job Description DUTIES / RESPONSIBILITIES Incorporate Process Safety and Risk Management principles into the foundation of all work performed.
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edc job in Dallas, TX
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