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Experience in Clinical systems like CTMS, CDMS, EDC, Veeva Vault, QMS and Safety Systems and Infrastructure Qualification. Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation strategy.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Activities to include: coordinating drawing changes and drawing releases with EDC-I team in India, developing DVP&Rs for the validation of the resourced components, coordinating specific validation steps in support of the DVP&R activities including metallurgical analysis, dimensional measurements, endurance testing, and performance testing.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Strong familiarity Medidata RAVE, Veeva EDC or Medrio. Ability to development/oversee Data Management specific documentation including but not limited to the eCRF specifications, eCRF completion guidelines, edit check specifications, validation documents, DMP and DRP (Data Review Plan.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Works with other functions to complete set up of EDC and other study data collection tools such as IRT, ePRO. Leads the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Bachelor's degree OR minimum 4 years of data management experience Minimum 2 years of Clinical Data Management experience (medical device / pharmaceutical industry preferred) Strong computer literacy (MS Word, Excel, PowerPoint) Strong verbal and written communication skills Electronic Data Capture (EDC) system experience including testing and validation Ability to travel up to 5.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Looking for a pure validation resource with periodic review, audit experience. Lead, Write, Review / Approve Requirement Traceability Matrix (RTM) and Validation Summary Reports. Maintain validation documentation throughout product lifecycle viz.as result of Change, Periodic Review, Audits Communication.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Maintain validation documentation throughout product lifecycle viz.as a result of Change, Periodic Review, Audits. Technical Lead (CSV, Clinical Systems) In this quickly changing economic landscape, virtual recruiting and remote work are critical for the future of work.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Maintain validation documentation throughout product lifecycle a result of Change, Periodic Review, Audits. To create project plans and keep track of schedule for on time delivery as per the defined quality standards.
ExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Oversee, develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Must Have Skills/Attributes: APQP, Creo, Design, Teamcenter. Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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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.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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This position requires working knowledge of clinical data management processes, Electronic Data Capture (EDC)/related applications, industry standards, and technical skills in working with data received from CROs and other external vendors.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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The incumbent will oversee outsourced studies ensuring appropriate interpretation and translation of the study protocol into validated data collection applications, tools, and systems (EDC, eCOA, IWRS), cleaning and validation of the data, and delivery of fit for use data for analyses.
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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.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Abstracts data from necessary sources to complete the EDC and resolve queries. The candidate will be coordinating clinical research protocols from study start up to close out. May be the sole coordinator or work in collaboration with a research nurse on studies, responsible for source documents, data collection, data entry, query resolution, triggering financial payments, study close out and liaison with the sponsor/CRO.
ExpandApply NowActive JobUpdated 4 days ago
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