Kristen

About Kristen

Data Management activities:Paper and EDC Studies:•Create paper CRFs from study protocol.•Conduct CRF review/approval meetings.•Provide CRFs for CRO conducted studies.•Create paper study CRF panel library.•Maintain paper study CRF standards in accordance with industry/government standards (CDISC, ISO, ANSI).•Review Edit Checks.•Create Test Data providing feedback to programmer.•Create Data Management Plan. •Identify Data Quality Listings.•Facilitate Data Quality review.•Ensure Data Management Timelines are met.•Clean Data throughout study life-cycle by reviewing the data. Coding activities:•Performing clinical coding utilizing MedDRA, WHO Drug and ATC assignment. •Perform any other coding duties including SOP creation.•Perform quality review of manually coded data in comparison to auto-coded data to assure consistency of coded terms. •Provide study specific Coding Guidelines for Data Management Plan.Attended project team meetings as the Data Management & Coding representative.

Experience

1. Senior Manager, Clinical Data Coding

   Jazz Pharmaceuticals

   May 2023 — Present

Education

• Monroe Community College

  A.A.S, Health Information Technology

  1994 — 1996

• SUNY Polytechnic Institute

  B.P.S., Health Information Management

  1996 — 1998

Skills

• Meddra
• Arisg5
• Clinical Trials
• Medical Devices
• Icd-9
• Certifed Meddra Coder
• Medical Coding
• Who Drug Dictionary
• Edc
• Data Management