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Safety Data Coordinator (Deerfield, IL)

Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. 1) Manage all aspects of data management tasks for multiple studies.
2) Design and create study databases within the clinical data management system including annotating case report forms with item names, devise database tables, data entry forms, determining code lists, and program edit checks.
3) Manage study databases through validation, identifying data discrepancies, finalizing resolutions, coding medications and adverse events using electronic dictionaries, and transfer of data to statistics. Applies understanding of FDA and ICH regulations when processing data.
4) Execute programs using SQL Plus and/or SAS to generate data listings and other ad hoc reports.
5) Interpret and extract data from clinical protocols to determine standard modules for case report forms
6) Design edit check specifications to ensure data integrity
7) Responsibility for the review of CRF and DCF data according to the WPDs and SOPs as well as the protocol. Also responsible for the resolution of any data discrepancies (Attachment A2).
QUALIFICATIONS: 1) Solid understanding of the clinical trial process including directives established by the FDA and ICH.
2) This position requires exceptional skills in the follow up areas: organizational thought and implementation, attention to timeline and detail, functional understanding of database design and utility, capacity to implement new computer software systems, and demonstrable priority management ability. (A1)
3) BS in Life or Computer Science or related area.
4) Post Graduate courses in specific technical areas a plus. 1-2 years experience in data management or other system/computer related fields.
As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits. To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V. If interested, please apply online at http://track.jobviper.com/ViewJob.asp?id=319991-1431-2317

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