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Crystal Nguyen

@crystalnguyen

Clinical Data Manager at Precision for Medicine leading oncology trial data management from study start-up through database lock.

United States

Message

At Precision for Medicine, I lead clinical data management activities from study start-up through database lock. I develop CRF specifications, coordinate EDC database build UAT, and work with database programmers to validate edit checks.

I also review and clean clinical trial data, perform medical coding and SAE/AE reconciliation, and coordinate vendor data transfers. Earlier at ECOG-ACRIN Cancer Research Group, I supported data freeze and database lock activities and reviewed data for melanoma studies.

Experience

Work history, roles, and key accomplishments

Current

Clinical Data Manager

Current

Precision for Medicine

Jan 2022 - Present (4 years 9 months)

Lead clinical data management activities from study start-up through database lock, including CRF development, EDC UAT, edit check specifications, data review, medical coding, and SAE/AE reconciliation.

Clinical Data Management Oncology Clinical Trials Database Building UAT Edit Check Specifications data review Query Management Medical Coding SAE AE Reconciliation data transfers Database Lock SAS Listings Study Metrics Cross Functional Collaboration Sponsor Communication

Clinical Data Associate II

Precision for Medicine

Feb 2021 - Jan 2022 (11 months)

Supported Lead Data Managers as backup and study team member, ensuring continuity and timely completion of data management activities. Performed quality control of clinical data entry and assisted with database builds and UAT.

Clinical Data Management Data Quality Control Database Building UAT Edit Check Review data review Query Management Medical Coding SAE AE Reconciliation SAS Programming Study Metrics

Clinical Data Associate II

ECOG-ACRIN Cancer Research Group

Sep 2019 - Feb 2021 (1 year 5 months)

Performed serious adverse event reconciliation between Medidata Rave and the National Cancer Institute safety database. Supported data freeze and database lock activities and assisted with edit check validation.

SAE Reconciliation Medidata EDC Database Freeze Database Lock Edit Check Review data review Quality Control Clinical Data Management

Clinical Data Associate I

ECOG-ACRIN Cancer Research Group

Jul 2018 - Sep 2019 (1 year 2 months)

Reviewed clinical trial data according to the Data Management Plan, generated manual queries, and resolved answered queries for melanoma studies. Ensured follow-up and survival data were accurately coded.

Clinical Data Review Query Management Medical Coding Data Management Plans (DMPs)CRF Completion Guidelines Data Entry Quality Control

Program Manager

Vietnamese American Services

Aug 2017 - Jan 2018 (5 months)

Managed Vietnamese Health Care Day activities at Mobile Med Clinic and assisted with grant applications for a Senior Health Care project. Supported community members with health insurance applications and established a community festival.

Program Management Grant Applications Community Outreach Health Insurance Support Event Management