Eunji Jang
Data Management Associate
Seoul
Summary
Clinical Data Manager with over 4 years of experience, capable of managing all aspects of clinical data management, from developing data management documentation and EDC setup to study closeout. Possesses strong communication skills, enabling effective collaboration with sponsors and research teams to ensure studies are responsibly conducted and successfully completed.
Overview
5
5
years of professional experience
16
16
Certifications
Work History
Data Management Associate
Symyoo
12.2019 - Current
- Experience in oncology study, global Phase III clinical trials, and MFDS inspections.
- Developed Case Report Form, Data Validation Specification, eCRF Completion guideline and other clinical data management relevant documents.
- Set-up the EDC accordance with Protocol
- Overall management of ongoing studies.
- Conducted Medical Coding (MedDRA and WHODD)
- Conducted data cleaning and query generation to clarify clinical data
- Conducted Data Review Meeting
- Managed Data Master File
- Communicated with Sponsor
Education
Bachelor of Science - Animal Biotechnology
Konkuk University
Seoul, South Korea 04.2001 -
Skills
Development of Documents Relevant to Clinical Data Management
Overall Data Management of Ongoing Studies
Written and Verbal Communication Skills
Medical Coding
SOP development
Languages
Korean
Native language
English
Upper intermediate
B2
Certification
1St Advanced Course for Good Clinical Practice Training (Konect)
Timeline
1St Advanced Course for Good Clinical Practice Training (Konect)
03-2023
CRS cube IWRS Course
03-2023
CRS cube CDMS Advanced 01 Course
03-2023
2023. 01CRS cube CDMS Advanced 02 Course
01-2023
Rave EDC SDBE for Data Validations Post Assessment
03-2022
Rave EDC SDBE for Data Managers Post Assessment
03-2022
SDTM010: Finding Domains(CDISC)
09-2021
5Th Advanced Course for Good Clinical Practice Training (Konect)
07-2021
DM통계분과 세미나(KSCD)
06-2021
CRS cube Builder Training Course (Basic)
10-2020
2Nd Intermediate Course for Data Management
09-2020
Data Management Associate
Symyoo
12.2019 - Current
Pfizer R&D University Training 13th
11-2019
Fundamental of Clinical Research & Practice
11-2019
Understanding of Applicable Regulatory Requirement
11-2019
Understanding of CRA Tasks During Clinical Trials
11-2019
Understanding of KGCP
10-2019
Bachelor of Science - Animal Biotechnology
Konkuk University
04.2001 -
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