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US-IL-McGaw: Clinical Data Manager

Date: 11-Jan-2011
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Sr Manager, Clinical Data Management

* Ensures that all data management tasks are conducted according to established policies and procedures * Develops CRFs, CRF completion guidelines, procedure requirements, data entry guidelines, database requirements, and data management plans * Develops and maintains study documentation * Serves as the primary data management study contact for project teams and vendors to ensure all project deliverables are met within established timelines * Performs protocol review, database and edit check testing, annotation of CRFs, quality assurance checks, quality control, SAE reconciliation, coding, and data entry * Trains and mentors junior members of data management staff * Develops and implements process improvement initiatives, SOPs, and work instructions * Serves as a subject matter expert for data management processes

* Mastery of Oracle Clinical data management processes, including data entry, discrepancy managment, coding, and lab subsystem maintenance * Mastery of all data management processes; competency in electronic data capture is highly desirable * Excellent oral and written communication skills * Excellent interpersonal skills * Excellent time management skills * Able to work effectively with cross functional groups * Able to multi-task easily * Bachelorís degree, preferably in scientific field * At least 5 years data management experience, including experience using Oracle Clinical * At least 1 year electronic data capture experience is highly desirable, preferably using Inform, RDC, and/or Rave

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Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/