Stephanie Elliott
Principal Data Manager @Chiesi USA, Inc.
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WORK HISTORY
Principal Data Manager @Chiesi USA, Inc.
Cary, NC, US
EDUCATION
College of Charleston
Bachelor of Business Administration (B.B.A.), Business, Management, Marketing, and Related Support Services
ABOUT STEPHANIE ELLIOTT
Experienced clinical research data management professional with a Bachelor of Business Administration (B.B.A.) focused in Business Management, Finance and Marketing from College of Charleston. Excellent technical skill with a knack for computer systems. Vast Lead data management expertise. Certified Medidata RAVE study builder, have managed many studies as lead DM across many indications. Expertise in management of timelines, vendor and external data, IRT integrations, managing of clinical databases/EDC, building CRFs, query management, reporting, system administration, overall EDC build, UAT testing. Background in Quality Assurance (including prepping, conducting and managing sponsor and intern audits to QMS Document preparation and QC), experience in various systems wearing many hats including CRA, Clinical Data Manager, QA Rep, System Admin, and have worked drafting and executing UAT scripts, competing change management control processes including drafting plan through validation of a system.Experience as both CDM and PM for an intermediate sized multi center compassionate use (Expanded Access Program) for terminally ill brain tumor patients (DIPG, Glioblastoma and Diffuse Midline Gliomas), tasks include all aspects of the project including site start up, negotiation of contracts, site activation, data review and management, monitoring and patient eligibility review. In addition to managing the expanded access program, responsibilities included database management (system admin) for an Oncology registry database platform within RedCap that is centered on all cancer types but with a primary goal to help both pancreatic and brain tumor cases; this includes but is not limited to overall database administration (primary admin), system change control and validation processes, creating and revising eCRFs in RedCap. Expert in many different platforms indicated above include:Trial Interactive TMFMedidata RAVE EDCMedrio BioclincaCerner, EPIC, MyChart, EMRs etc. MasterControl (admin)RedCap CLOUD EDC (admin) Hubspot (admin) Box (admin) Talent LMS (admin)Highly skilled in MS suite (excel, access, word, etc.), Clinical Data Management, Database administration, monitoring and remote review ensuring compliance.
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