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Familiarity with data acquisition platforms (EDC) Ensure data capture and maintenance will effectively meet the requirements of the protocol, expected project deliverables, and biostatistician requirements (if applicable.
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Design and develop data capturing tools: Electronic Data Capture (EDC) Systems (Eg: iMedidata Rave and IBM Clinical) eCOA, IRT; Manage electronic Trial Master File (eTMF) QC review eg: Veeva Vault; Lead the Audit and Inspection/Submission Readiness activities like documentation of QC and preparing Storyboards (Eg: FDA/EMA Submissions.
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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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Experience in Clinical systems like CTMS, CDMS, EDC, Veeva Vault, QMS and Safety Systems and Infrastructure Qualification. Experience in Clinical systems like CTMS, CDMS, EDC, Veeva Vault, QMS and Safety Systems and Infrastructure Qualification.
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The College is comprised of the Folsom main campus and its two educational centers, the El Dorado Center in Placerville ( EDC ) and the Rancho Cordova Center ( RCC ). Our Strengths Folsom Lake College centers student success by providing a broad range of degree and certificate programs and student support services in different modalities (including online and hybrid) that prepare students for transfer and/or career opportunities, as well as options for student engagement, innovation, and leadership.
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In addition to the skills listed, experience with other Informatica tools such as MDM, Axon, and EDC will be preferred. In addition to the skills listed, experience with other Informatica tools such as MDM, Axon, and EDC will be preferred.
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Champion people, process and technology improvements and standards to enhance quality, increase productivity (internal and external with Investigator sites) and reduce data latency within Quintiles clinical trial systems inclusive of IVxS, EDC, CTMS, QRPM, Data Factory, Triggers and Alerts, Visualizations such as Infosario Analytics and Federated reports, CDOS and SLDRs.
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Support study ad-hoc, interim, and final analyses through data review, including oversight of vendor data resulted and reported outside the electronic data capture (EDC). Through the application of gene editing and synthetic biology, we aim to enhance T-cell fitness to overcome the immunosuppressive tumor microenvironment, with the ultimate goal of inducing long-term responses in patients with solid tumors.
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Performs the following data related activities: EDC tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation and safety coding. Collects, verifies, organizes and records clinical information and data in electronic data capture systems (EDC.
$20 - $30 an hourPart-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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The position includes broad contact with HPD senior leadership, representatives from City Hall and City Council, as well as key partner agencies such as DCP, EDC, SBS, HDC, DSS, NYCHA, OMB, and DCAS.
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Actively participates in the development of common data standards and ensures EDC systems designs comply with the standards, as well as with associated protocol requirements. Establishes and maintains methodology used by the team to design and develop EDC systems, benchmarking against industry standards.
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Timely and accurately assist in collection, management, and shipment of subjects' samples, and/or specimens Completing Sponsor-required training prior to study-start, including, but not limited to Sponsor-provided and IRB-approved protocol All amendments Investigator Brochure Sponsor-specified EDC and/or IVRS This includes completing the above-mentioned training prior to any study-related procedures being conducted on that said protocol should the RA be added to a protocol post-study start.
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Accurately enters data from source documentation listed above, outside hospital records, and/or hard-copy research-specific documents, into study specific electronic data capture (EDC) systems for clinical research trials within 5 days of the patient visit EDCs include, but are not limited to, RedCap, Inform, Medidata Rave, Viva Vault, and Trial Master.
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EDC experience - Database Builds / Study Start up / DB Locks. EDC experience - Database Builds / Study Start up / DB Locks. The company has a strong Rare Disease / Cardiovascular pipeline, and will be starting a Phase III as well as working on a couple of early Phase I/II studies in Q2.
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Enforces processes for effective data management in an electronic database (EDC), electronic trial master files (eTMF), electronic patient-reported outcomes (ePRO), and Clinical Trial Management System (CTMS.
Full-timeExpandApply NowActive JobUpdated 3 months ago
edc job
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