Yanghee K. - Project Manager

Go to Website

Yongin-si, Korea, Republic of

Experience

Sep 2023 - Feb 2025

1 year 6 months

Korea, 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 and local regulatory requirements.

Apr 2023 - Aug 2023

5 months

Cheonan-si, Korea, Republic of

Lecturer, Pediatric Nursing

NamSeoul University, Department of Nursing

Mar 2022 - Apr 2022

2 months

Manila, 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 months

Korea, 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.
Make project related decisions 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 and countries for implementation of clinical research.

Feb 2018 - Apr 2020

2 years 3 months

Korea, Republic of

Clinical Research Manager, Country Manager

PHARM-OLAM INTERNATIONAL

Oversee country operations including people management.
Act as primary contact of global project team and provide country specific requirements and local knowledge for IRB/RA submission.
Engage in country business development as a local technical expert.
Perform feasibility and 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 months

Korea, Republic of

Manager, Clinical Operations & Quality Management

International Vaccine Institute

Supervised daily operations and management of activities of 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 CROs for site management and RA in developing countries.
Developed SOPs and work instructions for the clinical development department.
Developed electronic Trial Master File system for the IVI.

Oct 2014 - Feb 2016

1 year 5 months

Korea, Republic of

Senior Manager, Quality Management, Clinical Operation Frontiers Group

Samsung Bioepis

Provided professional quality management to projects and managed CRO activities.
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 on-site QC visits, data QC, and document QC (on e-TMF, sponsor TMF file) to ensure high quality of data/documents and project deliverables.
Conducted overseas inspection readiness visits for EMA and MFDS and established CAPA in collaboration with SMEs.
Led and established the quality management team and maintained effective communication within the clinical team and with other teams involved in clinical projects.

Oct 2010 - Oct 2014

4 years 1 month

Korea, 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 a public health setting in rural India.
Served as point of contact at IVI on the Global Health Clinical Consortium (GHCC) initiated by the Bill & Melinda Gates Foundation and 13 other product development partners.
Served as a member of IRB at IVI.
Monitored Phase II-IV clinical trials in India for GCP compliance according to protocol and relevant guidelines.
Participated in development of study protocols and related documents.
Oversaw CRO activities 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 months

Korea, 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 (Clinical Research Coordinators).
Developed a two-year professional training program for CRCs (Clinical Research Coordinators).
Developed the Clinical Trial Management System for site staff.
Participated in writing protocols.
Conducted audits for Investigator Initiated Trials (IITs) on sites and led preparation for inspections and audits by global pharmaceutical companies.
Mentored senior research staff on project management procedures and policies.

Apr 2003 - Sep 2010

7 years 6 months

Korea, Republic of

Project Coordinator, Multi-national Multi-site Phase 3 Investigator Initiated Trial in Lung Cancer

Samsung Medical Center

Coordinated 35 participating sites (Korea, China, Taiwan).
Developed e-CRF and managed e-trial.
Collaborated 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 for internal QA.
Conducted interim analysis and prepared abstract for ASCO.

Feb 2000 - Feb 2002

2 years 1 month

Korea, Republic of

Registered Nurse, Endocrinology Unit

Asan Medical Center

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 in developing country settings (India, Bangladesh, Philippines, Thailand, etc), 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, both in developed and in developing country settings
Skilled in development of a 2-years Professional Training Program for CRC (Clinical Research Coordinators) and which is still in place and used today