Clinical System

SHELIA STEPHENS

**** *** ***** ******

Pittsburg, CA 94565

206-***-**** www.linkedin.com/in/sheliamstephens ********@***.***

SUMMARY

Accomplished Clinical Data Manager (CDM) with expertise in medical device, biotechnology and

pharmaceutical organizations, especially in Electronic Data Capture (EDC). Detail-oriented with

strong capability of handling multiple tasks simultaneously, strong aptitude to work under

pressure and meet strict timelines. Proven to constantly enhance EDC system with new features

improving clinical trial process, reducing overall cycle time and data quality with greater cost

effectiveness.

TECHNICAL SKILLS

Rave 5.4.1 Accelerate Training

Rave 5.6.4 Amendment Manager Upgrade

Rave 5.6.2 Query Management, Script Utility / Script Utility Manager, and User / Site

Administration

Rave Targeted SDV1.1 Configuration and Subject Management

Rave Batch Uploader Overview, Understanding Configurations, Additional Configuration

Options and Settings

Rave Web services Workshop

Rave Report Packager and Business Objects (BOXI)

PROFESSIONAL EXPERIENCE

JANSSEN ALZHEIMER IMMUNOTHERAPY, a J&J Company, (investment with Élan) 03/2008 – 04/2013

South San Francisco, CA

Associate Director, Data Management

Managed Contract Research Organization overall planning, implementation and execution of clinical t rials

in various stages from planning, to start-up, conduct, closeout, and archiving within clnincal data

management. Participated and provided expert-level advice and direction at study team meetings for Clinical

Data Management. Provided leadership in the areas of project planning, team assignments and resource

management, process improvement, and training to ensure departmental goals are met.

• Developed, implemented and maintained EDC standards used to improve system development life

cycle by utilizing CDISC, particularly CDASH and SDTM.

• Reduced manual Rave training 20% by implementing eLearning applications, supporting training and

development team.

• Facilitated and implemented data integration by reducing manual review and reconciliation of external

data and uploading data into Rave via Batch Uploader.

• Introduced, planned and coordinated user acceptance testing of Rave Targeted Source Data

Verification, reducing on-site monitoring.

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SHELIA STEPHENS PAGE TWO

ADVANCED BIO-LOGICS SOLUTIONS CORP, Thousand Oaks, CA 11/2007 – 02/2008

Clinical Data Manager (Contractor)

Reviewed and configured Rave core EDC system for Élan while providing expertise in study build.

• Created effective and efficient clinical databases, utilizing Rave 5.6.1 and 5.6.2.

• Provided expertise and guidance in design, implementation and maintenance of EDC system.

• Review data for quality oversight and provided feedback to data team leads.

AMGEN INC, Thousand Oaks, CA 07/2002 – 11/2007

Senior Clinical Systems Specialist 2006 – 2007

Clinical Systems Specialist II 2002 – 2005

Provided business process and technical expertise to facilitate adoption and use of standard technologies

for data and trial management while ensuring high quality clinical system is ready to support study team

needs.

• Developed multiple Rave and Oracle Clinical systems through all study phases for oncology,

nephrology and inflammation therapeutic areas.

• Wrote and executed validation scripts for Rave upgrades which prevented software problems from

reaching production environments.

• Contributed to CRF design process and edit check specification development by identifying possible

design issues relating to database builds, increasing cycle time by 15 – 20%.

• Initiated and facilitate study team review and data modeling discussion, defining optimal database

design and database structures for both EDC and Oracle Clinical.

ADDITIONAL PROFESSIONAL EXPERIENCE

IMMUNEX CORPORATION, Seattle, WA 09/1992 – 06/2002

Database Administrator

Senior Data Management Associate

Clinical Data Analyst

Senior Data Entry Operator

Data Entry Operator

BAXTER HEALTHCARE NOVACOR DIVISION, Oakland, CA

Data Entry Clerk

EDUCATION

BS, Information Technology, University of Phoenix, Woodland Hills, CA, 2003

Professional Courses Completed: Technical Writing, How to be a Better Communicator

Speak with Confidence, Medical Terminology, Anatomy and Physiology,

Human Diseases and Survey of Health Care Delivery

PROFESSIONAL CERTIFICATIONS

Data Processing – Junior Programming, Heald Business Co

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