LINDA MOODY BROWN

**** ******* ***** * **** STROUDSBURG, PA 18302 ٠-570-***-****

E-MAIL - quex01@r.postjobfree.com

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Experience:

1997-2010 Sanofi Pasteur Swiftwater, PA

Administrative Coordinator

•Designed and validated Case Report Forms (CRF), Diaries and Memory Aids (in line with project and global standards) using Microsoft Word.

•Developed the Annotated Case Report Form (eCRF) within the Inform Architect Design Tool for the use of web based electronic data capture.

•Collaborated with US, Europe and Canada Clinical Teams in the development of CRF Design documents and revisions until finalization.

•Organized and led the validation review meetings/videoconferences with respect to milestones determined by the Clinical Team.

•Responsible for launching all Data Collection Documents through the Electronic Data Management System (Documentum) lifecycle until finalization.

•Promote the CRF Design activity within and outside the Data Management Platform through conferences in order to present as well as clarify CRF design related issues.

•Maintained up to date of all Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and administrative documents for the CRF design activity as well as the Clinical Data Management process.

•Scanned and archived the related paper and electronic trial documents in the Trial Master Files (TMF) via Documentum.

Clinical Data Coordinator

•Reviewed clinical trial data in accordance with (Global) Data Management Plans and applicable standardized data management processes to identify erroneous, missing incomplete or implausible data.

•Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification/correction to the database.

•Applied quality control procedures and checks to ensure data quality standards are achieved.

•Assist in the development and testing of data management system edit/data validation checks and special listings/procedures used as tools for the data review and discrepancy management activities.

•Tracked Case Report Forms to ensure all forms are received in house at the end of the trial.

Initiated and maintain trial related reference binders.

Senior Data Technician

•Accurately entered verbal and numerical data from clinical trials into computer programs for statistical analysis in preparation for FDA submission.

•Generated verification reports and made the necessary corrections to study database.

•Ensured quality data was submitted to Quality Assurance by performing Quality Control reviews of the clinical data that has been entered in the clinical database.

•Imported, scanned, cleaned and reviewed all subject CRFs with Serious Adverse Events (SAE) to ensure all pertinent source documentation were included prior to Book marking and Hyper linking for the first electronic submission to the FDA for a vaccine.

1990 – 1996 Richard Allen Center On Life New York, NY

Administrative Assistant

•Provided direct support to the Director for Adoption Services.

•Managed telephone, emails and correspondence; made travel arrangements; scheduled appointments and meetings.

•Maintained files, records and conduct research to ensure accuracy of information.

•Maintained inventory of supplies and equipment.

Education: Northampton Community College

Completed 35 credits toward AAS in Business Management

Medical Terminology Certification

March 2011

Technical Skills: Microsoft Office Suite, Internet Explorer, SAP, Inform EDC System, Inform Architect Design Tool, ClinTrial 4.0, Clinical Documentum Electronic Data Management Software, Adobe ISI Toolbox, Oracle