Nahyun Lee
21, Saemal-ro 15-gil, Songpa-gu, Seoul, Republic of Korea
Summary
Dedicated clinical data manager with 5+ years of experience in data management, EDC development, and clinical trials. Skilled in Medidata Rave and CRScube with a deep understanding of clinical trial processes, data collection standards, and client engagement. Proven ability to lead multiple projects and mentor junior team members in fast-paced environments.
Overview
4
4
years of professional experience
9
9
years of post-secondary education
25
25
Certifications
Work History
Sr.DMA, Data Management
C&R Research
6 2024 - Current
- Perform key Clinical data management activities such as Data collect, review through DM cycle with quality.
- Working in Conduct phase and performing activities such as Query Management, Data review generating queries.
- Managed and developed EDC or RTSM System and system validation process for clinical data management supporting global and local studies in various therapeutic areas.
- Led EDC development projects, ensuring seamless implementation according to Good Clinical Data Management Practices (GCDMP).
- Maintaining good collaboration and communication with my study peers, Study team members to deliver standard of work as per Client expectation.
- Provided training and mentorship to junior team members.
Clinical Data Manager/Biostatistician, Clinical Research
HYUNDAIPHARM.CO.,Ltd
10.2023 - 04.2024
- Collaborated with cross-functional teams to design clinical data specifications and statistical analysis plans.
- Supported clinical trial data collection, handling, and quality control across multiple studies.
Sr.DMA, Data Management
C&R Research
01.2023 - 10.2023
- Perform key Clinical data management activities such as Data collect, review through DM cycle with quality.
- Managed and developed EDC or RTSM System and system validation process for clinical data management supporting global and local studies in various therapeutic areas.
- Provided training and mentorship to junior team members.
DMA, Data Management
C&R Research
04.2020 - 12.2022
- Perform key Clinical data management activities such as Data collect, review through DM cycle with quality.
- Managed and developed EDC or RTSM System and system validation process for clinical data management supporting global and local studies in various therapeutic areas.
Education
Master’s Degree - Health Informatics & Biostatistics
Yonsei University
Seoul, Korea 03.2023 - 05.2023
Bachelor’s Degree - Statistics and Actuarial Science
Soongsil University
Seoul, Korea 03.2011 - 05.2020
Skills
SAS, R Programming
SQL Programming
MS Word, MS Excel, Power point
Development and Management of EDC System(Medidata RAVE, CRScube)
Data Management
Data Cleansing
Database Design
Data Migration
Data Quality Assurance
Teamwork and Collaboration
Keep good Communication with my co-workers
Certification
Microsoft Office Specialist office PowerPoint 2007, KpBn-wsP4, Country
Clinicaltrial experience
- Nervous System / Alzheimer's Disease, Phase II, Global Study, Data management Associate, Data Management(CRScube)
- Oncology / diffuse large B-cell lymphom, OS, Local Study, EDC Builder, EDC development(CRScube)
- Oncology / Prostate cancer, Phase I/II, Local Study, Data management Associate, Data Management(CRScube)
- Insomnia Disorder, Phase III, Local Study, Data Management Associate, Data Management(Medidata)
- Immunology / Chronic graft versus host disease, Phase II, Local Study, Data Management Associate, Data Management(CRScube)
- Cardiology / Dyslipidemia, Phase I, Local Study, Clinical Data Manager, Data management, EDC development(CRScube)
- Cardiology / Dyslipidemia, Phase I, Local Study, Biostatistician
- Cardiology / Dyslipidemia and Hypertension, Phase I, Local Study, Clinical Data Manager, Data management, EDC development(CRScube)
- Respiratory Medicine / idiopathic pulmonary fibrosis, Phase I, Local Study, Clinical Data Manager, Data management, EDC development(CRScube)
- Endocrinology / Diabetic Dyslipidemia, IIT, Local Study, Clinical Data Manager, Data management, EDC development(CRScube)
- Moderate to severe Glabellar lines, Phase I, Local Study, Data Management Associate, Data management(CRScube)
- Gastroenterology / Chronic hepatitis B, Phase I, Local Study, EDC Builder, EDC development(Medidata)
- Orthopedics / Osteoarthritis, Phase I/II, Local Study, Data Management Associate, Data management(CRScube)
- Orthopedics / Knee Osteoarthritis, Phase I/II, Local Study, Data Management Associate, Data management(Medidata)
- Gastroenterology / Laryngopharyngeal Reflux Disease, IIT, Local Study, Data Management Associate, Data management(CRScube)
- Cardiology / Dyslipidemia and Hypertension, Phase III, Local Study, IWRS Builder, IWRS development(CRScube)
- Oncology / Solid tumors, Phase I, Local Study, EDC Builder, EDC development(Medidata)
- Oncology / Breast cancer, Phase III, Global Study, Data Management Associate, Data management(Medidata)
- Dermatology / Atopic dermatitis, Phase III, Local Study, Data Management Associate, Data management(Medidata)
- Neurology / Peripheral neuropathy, PMS, Local Study, Data Management Associate, Data management(CRScube)
- Ophthalmology / Glaucoma, Phase I, Local Study, EDC Builder, EDC development(CRScube)
- Endocrinology / Hyperlipidemia, Phase I, Local Study, Data Management Associate, EDC Builder, Data management, EDC development(CRScube)
- Cardiology / Hypertension, Phase IV, Local Study, Data Management Associate, Data management(CRScube)
- Urology / Overactive Bladder, Phase I, Local Study, Data Management Associate, Data management(Medidata)
- Lymphoscintigraphy, Phase I, Local Study, EDC Builder, EDC development(LeadTrial)
- Respiratory Medicine / Acute & Chronic bronchitis, PMS, Local Study, Data Management Associate, EDC Builder, Data management, EDC development(LeadTrial)
- Ophthalmology / Diabetic Macular Edema, Phase IV, Local Study, Data Management Associate, Data management(CRScube)
- Endocrinology / Diabetic Dyslipidemia, PMS, Local Study, Data Management Associate, Data management(CRScube)
- Oncology / Colorectal cancer, PMS, Local Study, Data Management Associate, Data management(LeadTrial)
- Benign Masseteric Hypertrophy, Phase II, Local Study, EDC Builder, EDC development(CRScube)
- COVID-19, Phase II, Local Study, EDC & IWRS Builder, EDC & IWRS development(CRScube), Data Management Associate, Data management(CRScube)
Languages
Korean
Native language
English
Upper intermediate
B2
Timeline
Clinical Data Manager/Biostatistician, Clinical Research
HYUNDAIPHARM.CO.,Ltd
10.2023 - 04.2024
Master’s Degree - Health Informatics & Biostatistics
Yonsei University
03.2023 - 05.2023
Sr.DMA, Data Management
C&R Research
01.2023 - 10.2023
DMA, Data Management
C&R Research
04.2020 - 12.2022
Bachelor’s Degree - Statistics and Actuarial Science
Soongsil University
03.2011 - 05.2020
Sr.DMA, Data Management
C&R Research
6 2024 - Current
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