Yanghee Kim
Project Manager
Experience
Sep 2023 - Feb 2025
1 year 6 monthsKorea, Republic of
Project Manager
ABION Inc.
- Lead project management of Phase II oncology clinical trial with NSCLC: oversee the end-to-end planning, execution and monitoring, ensuring timelines, budget, and quality standards. Coordinated cross-functional teams, including regulatory affairs, DM, pre-clinical part.
- Manage project of compassionate use of investigational drug: assessing feasibility and regulatory pathways to proceed the project outside of clinical trials. Met the reporting requirement from Korean FDA during the project.
- Successfully led the setup of a comprehensive PV system, ensuring compliance with global regulatory requirements as well as local requirements.
Apr 2023 - Aug 2023
5 monthsCheonan-si, Korea, Republic of
Pediatric Nursing Lecturer
Department of Nursing, NamSeoul University
Mar 2022 - Apr 2022
2 monthsManila, Philippines
Consultant – Clinical Trials
WHO WPRO
- Provided support to the regulatory systems strengthening program within EMT team in the development and implementation of strategies and actions in strengthening Member States’ clinical trial oversight with particular focus on COVID-19 vaccine introduction in the Western Pacific Region.
Jun 2020 - Feb 2022
1 year 9 monthsKorea, Republic of
Clinical Development Team Lead
ICM Co., Limited
- Project management for FIH trial of gene therapy in Australia and USA.
- Writing protocol, study tools, and all-round support in conducting clinical trials.
- Manage vendors (CRO, bioanalytical lab, imaging lab and IP vendor, etc.) from selection stage and monitor the quality of vendors with deliverables and address quality issues.
- Project-related decision making such as site selection, recruitment and retention, budget and risk management planning at country and site level.
- Contribute to developing new clinical development of other target areas.
- Identify potential partners/countries for implementation of clinical research.
Feb 2018 - Apr 2020
2 years 3 monthsKorea, Republic of
Clinical Research Manager, Country Manager
PHARM-OLAM International
- Oversee country operations including people management.
- Primary contact of global project team and provided country-specific requirements and local knowledge for IRB/RA submission.
- Engage in country business development as a local technical expert.
- Perform feasibility and/or site identification activities.
- Oversee regulatory vendor by reviewing regulatory documents for quality and present status to sponsor.
- Manage clinical supplies vendor.
- Provide support in study development and start-up activities.
Mar 2016 - Jan 2018
1 year 11 monthsKorea, Republic of
Manager, Clinical Operations & Quality Management
International Vaccine Institute
- Supervised daily operations and management of activities to CRAs.
- Planned, prepared, and executed vaccine clinical trials against cholera and typhoid fever in developing countries (Bangladesh and Philippines) with partners and global CROs.
- Conducted quality management activities in vaccine trials in developing countries.
- Managed CRO for site management and RA in developing countries.
- Developed SOPs/WIs for the Clinical Development department.
- Developed electronic Trial Master File System for the IVI.
Oct 2014 - Feb 2016
1 year 5 monthsKorea, Republic of
Senior Manager, Quality Management, Clinical Operation Frontiers Group
Samsung Bioepis
- Provided professional quality management to projects and managed CRO.
- Developed and maintained quality management processes for the company.
- Developed SOPs, manuals, guidelines, and training programs for clinical team members and provided hands-on training.
- Performed quality control activities such as on-site QC visits, data QC, document QC (on e-TMF, sponsor TMF file) to ensure high quality of data/documents and project deliverables.
- Performed overseas inspection readiness visits for EMA and MFDS, and established CAPA in collaboration with SMEs.
- Led and established quality management team and maintained sound working relationships and effective communication within the clinical team and with other teams involved in clinical projects.
Oct 2010 - Oct 2014
4 years 1 monthKorea, Republic of
Research Associate, Associate Research Scientist/Epidemiologist
International Vaccine Institute
- Implemented and supervised phase II-IV vaccine clinical trials against cholera as the project coordinator.
- Planned, implemented, and supervised a mass vaccination campaign using an oral cholera vaccine in public health setting in rural India.
- Served as the point of contact at the IVI on the Global Health Clinical Consortium (GHCC) initiated by the Bill & Melinda Gates Foundation and 13 other partners.
- Served as a member of the IRB at the IVI.
- Monitored phase II-IV clinical trials in India for GCP compliance according to protocol and guidelines.
- Participated in development of study protocols and related documents.
- Managed CRO oversight in site management and RA activities in Thailand and India.
- Coordinated DSMB constitution and communication and prepared required documents (charter, SOP).
- Prepared manuscripts for peer-reviewed publication.
Apr 2003 - Sep 2010
7 years 6 monthsKorea, Republic of
Manager, Dedicated Oncology Clinical Research Coordinators Team
Samsung Medical Center
- Managed oncology clinical trials operation, leading the clinical research team to ensure on-time and on-budget performance.
- Supervised, trained, and mentored a clinical research team of 45 staff (CRCs).
- Developed a two-year professional training program for CRCs.
- Developed the Clinical Trial Management System for site staff.
- Participated in writing protocols.
- Conducted audits for investigator-initiated trials on sites and led inspections and audits by global pharmaceutical companies.
- Mentored senior research staff on project management procedures and policies.
Feb 2000 - Feb 2002
2 years 1 monthKorea, Republic of
RN, Endocrinology Unit
Asan Medical Center
Korea, Republic of
Project Coordinator, Multi-national Multi-site Phase 3 IIT in Lung Cancer
Samsung Medical Center
- Coordinated 35 participating sites (Korea, China, Taiwan).
- Developed e-CRF and managed e-trial.
- Worked on study protocol development with coordinating investigators.
- Supervised CRO for site monitoring visits and vendor for data management.
- Organized international and local investigator meetings and presented study status and safety issues.
- Conducted CRC trainings for sites in Korea.
- Conducted site monitoring visits in Korea as internal QA.
- Conducted interim analysis and prepared abstract for ASCO.
Summary
- An experienced professional in the Clinical Research Industry for over 20 years in multiple fields (Pharma, global CRO, biotech venture, international organization, and hospital) and multi-therapeutic areas (vaccines, human gene therapy, oncology, etc.)
- Experience in planning, implementation and monitoring of clinical trials, including infectious disease surveillance and vaccine delivery projects using public health infra-structure, and management of research staff
- Extensive experience in Project Management, Clinical Operations and Quality Management (EMA, US-FDA and MFDS Inspection) both in international and domestic settings
- Experience in building and managing relationships with investigator sites and other stakeholders, in planning, implementing, and monitoring of various phases of clinical trials
- Skilled in development of a 2-years Professional Training Program for CRC (Clinical Research Coordinators) and which is still in place and used today
Languages
Korean
NativeEnglish
AdvancedEducation
Sep 2017 - Aug 2019
Graduate School of Nursing, Chung-Ang University
PhD (ABD) · Nursing · Korea, Republic of
Mar 2005 - Aug 2008
Graduate School of Public Health, Yonsei University
Master of Public Health · Public Health · Korea, Republic of
Mar 1996 - Feb 2000
Chung-Ang University
Bachelor of Science in Nursing · Nursing · Korea, Republic of
Certifications & licenses
Certified Local Surveyor
FERCAP: Forum for Ethical Review Committee in the Asian & Western Pacific Region
Certified Local Surveyor
FERCAP: Forum for Ethical Review Committee in the Asian & Western Pacific Region
Certified Local Surveyor
FERCAP: Forum for Ethical Review Committee in the Asian & Western Pacific Region
Certified Clinical Research Professional (CCRP)
Society of Clinical Research Associates (SoCRA)
Certified Clinical Research Coordinator (CCRC)
Association of Clinical Research Professionals (ACRP)
Certificate of Registered Professional nurse in the state of N.Y.
University of the State of N.Y.
Certificate of Health Teacher
ministry of Education & Human Resources Development, Seoul. Korea
Certificate of Registered Nurse
ministry of Health & Social Work, Seoul, Korea
Need a freelancer? Find your match in seconds.
Try FRATCH GPT More actions
Similar Freelancers
Discover other experts with similar qualifications and experience
Seongdo Choi
Freelance Data Annotator
View Profile
Niels Adams
Consultant: Translational Sciences
View Profile
Fatima Boumares
Clinical Affairs & Evaluation Team Lead
View Profile
Michal Konstacky
Managing Director/Consultant
View Profile
Joachim Bier
Consultant Medical Affairs & Clinical Affairs
View Profile
Dany-armand Djeudeu-deudjui
Senior Data Scientist
View Profile
Ezgi Aydöre
Bioinformatics Intern
View Profile
Jean Mckinney
Writer/Designer
View Profile
Ehsan Amin
Clinical Data Scientist
View Profile
Desalegne Syit
Medical Device Auditor (ISO 13485, ISO 9001)
View Profile
Olivier Ménage
Co-founder and CEO
View Profile
Chunnan Chen
Freelance Consultant
View Profile
Juergen Mehring
Freelancer
View Profile
Wonjung Lee
Korean Bilingual Generalist - AI Training Specialist
View Profile
Bruno Pirovino-zürcher
Executive Director / Board Member
View Profile
Tejas Parve
Junior Data Manager (Clinical Data Management)
View Profile
Estelle Kamwa
Document Management / Document Controlling Specialist
View Profile
Dirk Bremen
Freelance Interim Management
View Profile
Trịnh Tấn
Maker and Reviewer – AI Trainer – Biology and Basic Medical Science Expert
View Profile
Detlef Nehrdich
DM Director
View Profile
Andreas Seidl
Interim Head of Risk Management and Usability
View Profile
Vidmantas Palsis
General Practitioner
View Profile
Ralf Patsch
Data Integration Consultant
View Profile
Monika Weber
Quality Specialist
View Profile
Felix Kluge
Senior Data Scientist
View Profile
Alexander Burstein
AI Trainer (freelance)
View Profile
Aman Maharjan
Guest Researcher
View Profile
Anja Żalik
Managing Consultant
View Profile
Georg Van husen
Non-Executive Board Member
View Profile
Mei-fang Chen
Medical Consultant
View Profile
