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Admin experience with Informatica any of these modules- EDC, AXON, B2B, BDM, MDM. Admin experience with Informatica any of these modules- EDC, AXON, B2B, BDM, MDM. Provide technical support for the administration and production support of Informatica.
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Sets up and conducts studies in compliance with the protocol, SOPs, applicable regulations, and GCPs. Prepares, completes, organizes, and maintains all study documentation forms, including drafting protocol amendments, case report forms, Electronic Data Capture (EDC), and other study-specific documents.
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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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Serve as UPN Ambassador by participating in Community, Chamber and EDC networking events. Serve as UPN Ambassador by participating in Community, Chamber and EDC networking events. The Account Director will be responsible for managing the sales cycle and forecast accurately in a customized CRM model.
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Implementing UPN's go-to market strategy around its entire product portfolio to include voice services, bandwidth solutions associated with internet access and metro optical Ethernet products. Experience in hunting, prospecting, and new account development.
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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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This includes responsibility for the compilation and transcription of research patient data and study-related information into case report forms (CRFs) into sponsor specific electronic data capture systems (EDC.
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Support CRFs development, data mapping specifications, DVP, DMP, and data transfer specifications and tests EDC system functionalities. Support CRFs development, data mapping specifications, DVP, DMP, and data transfer specifications and tests EDC system functionalities.
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The Sr. Clinical Data Manager will be responsible to support all aspects of data management from study start-up to database lock including EDC design, data review/cleaning, query management, data reconciliation, and data transfer specifications.
$150,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Experience with various data collection and Electronic Data Capture (EDC) systems and related tools and processes. Perform and manage all data cleaning activities, including processing queries, performing ongoing data review, and orchestrating scheduled cross-functional data review/reconciliation, identifying issues, data trends and tracking them through resolution.
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Requirements: BA/BS degree along with at least 5 years of clinical data management experience which includes 3 years in a DM lead role and 1-2 years of experience in developing clinical trials databases in a commercially available EDC system (e.g. RAVE, Medrio, Red Cap, Veeva); Medidata RAVE build certification 5.6.
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Ensure proper completion of UAT of EDC system and modules. Review/prepare training materials and user guides for EDC data collection tools, deliver user training. Work with DM leads and DB programmers to design (e)CRFs and edit checks in EDC system.
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Perform data review via listings and EDC system, issue and resolve queries. Work with database programmers to design (e)CRFs and edit checks in EDC system. Minimum 1 year acting as a Lead Data Manager on one or multiple projects (study start up through database lock.
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Ensures the quality of clinical data within the EDC and other databases through data review and data reconciliation processes and communicates any outstanding issues. ResponsibilitiesIndependently leads EDC development, including CRF development, EDC specification process, edit check development and User Acceptance Testing including test scripts and execution logs, issue logs, and UAT summary reports.
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Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug. Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed.
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