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Manage and oversee EDC system configuration, EDC Build, and integrations with EDC. Create and own database build SOPs and processes. 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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Use experience with: SAS and programming languages for derived analysis datasets and TFLs; XML, Pinnacle 21; handling and processing of upstream data (multiple data forms, workflow, eDC, SDTM); providing outputs to meet downstream requirements (ADaM, Data Definition Table, e-submission); and CDISC standards and relational database to p rovide comprehensive programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of BMS products.
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Working knowledge of database applications, such as Microsoft Access (including Structured Query Language; SQL) and EDC systems. Create specifications and work with internal software teams to design highly efficient tools to organize and report on clinical and analytical study data from multiple sources (hard-copy CRFs, EDC systems, SLC BIOFIRE run database, Microsoft Excel spreadsheets, etc.
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Strong experience of EDC systems, especially Medidata Rave. Lead and oversee the vendor in data management activities including database build, data review, and database lock, following requirements defined in the clinical protocol and in alignment with industry best practice guidelines and Caribou Clinical Development data standards and processes.
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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.
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Proficiency with Microsoft Office suite and patient database software, Electronic Data Capture (EDC). Trains and develops staff to ensure operational objectives for ST conform to all relevant federal and state laws, regulations, guidelines; clinical research protocols, internal SOPs and WIs.
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The Research Database Manager (RDM) will be responsible for creating data collection approaches, management, development, and delivery of several research databases in the Department of client; Work collaboratively with clients multi programs, Clinical Research and Analytics cores.
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Experience with DICOM viewing applications and PACS systems Experience in a Core Lab setting and Database Development Medical Imaging Transfer Application experience. 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.
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EDC( Enterprise Data Catalog) SQL Server database. MDM Master Data Management. EDC( Enterprise Data Catalog) IDQ (Informatica Data Quality) Only USC or GC or GC EAD. SQL Server database.
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Manage study activities including, but not limited to, investigator selection, study start-up, subject recruitment & retention, data collection, development of study plans, and database locks, study drug accountability and study closeout.
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Computer skills should include proficiency with Microsoft Office suite of software, electronic TMF systems, IXRS and EDC systems. Provide operational and strategic input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
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Working knowledge of EDC systems preferably Medidata RAVE. Reporting to the Sr. Director, Data Management, the Director, Data Management is responsible for the oversite of Data Management vendors to ensure timelines and deliverables are met and is accountable for all aspects of the clinical trial data management process from study start up through database lock, including escalations of issues when necessary.
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Knowledge of relational database design, FDA regulations (particularly 21 CFR Part 11), web-based Electronic Data Capture (EDC) is also required. Work collaboratively with Clinical Data Management, Statistical Programming, Biostatistics, Clinical Operations and Clinical Development to meet project deliverables.
$130,220 - $168,520Full-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Experience with managing Informatica Enterprise Data Catalog (EDC), Axon, Data Privacy Management (DPM), and Data Masking application environmentsExperience with managing MDM and ETL data application environmentsExperience with defining and maintaining data architecture, accuracy, consistency, and securityStrong familiarity with Oracle, MSSQL Server, MySQL, DB2, etc.
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In addition to the skills listed, experience with other Informatica tools such as MDM, Axon, and EDC will be preferred. 8 years experience working on Enterprise Scale database solutions, such as Oracle, SQL Server, Snowflake, and similar.
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