임창선 Email & Phone Number

Korea

- Overvall management of Clinical Research team in oncology/Immuno oncology area from feasibility, start-up to study closure (Present)1. Global Ph I~III studies in NSCLC, H&N Ca., Breast Ca.2. Global Ph II, III studies in Bladder Ca., Ovarian Ca., Prostate Ca., HCC, Gastric Ca. - Experience to manage the clinical research team conducting cardiovascular, respiratory, endocrinology and the other non-oncology studies TAs for 2 years- Experience to lead MFDS GCP inspection for… Show more - Overvall management of Clinical Research team in oncology/Immuno oncology area from feasibility, start-up to study closure (Present)1. Global Ph I~III studies in NSCLC, H&N Ca., Breast Ca.2. Global Ph II, III studies in Bladder Ca., Ovarian Ca., Prostate Ca., HCC, Gastric Ca. - Experience to manage the clinical research team conducting cardiovascular, respiratory, endocrinology and the other non-oncology studies TAs for 2 years- Experience to lead MFDS GCP inspection for NDA with good result- Accountable for delivering the comitted part of all clinical interventional studies under my supervision according to agreed resources, budget and timeline complying with SOP, international guideline such as ICH-GCP as weel as relevant local regulations- line manager for all assigned personal plus other responsibilities as required (Project leaders, CRAs and CTAs) and to lead local study team(s) and perform monitoring as needed Show less

Korea

- Co-ordinate the implementation of global and local clinical development process, clinical procedural documents, Quality & Compliance Manual documents- Co-ordinate training on all the above to relevant staffs, according to plans and ensure the training records for all relevant staffs are maintained-Support the clinical research team in the resolution of issue found in audits, inspections- Give regular feedback on QA findings to relvant staffs.- Experience to lead country… Show more - Co-ordinate the implementation of global and local clinical development process, clinical procedural documents, Quality & Compliance Manual documents- Co-ordinate training on all the above to relevant staffs, according to plans and ensure the training records for all relevant staffs are maintained-Support the clinical research team in the resolution of issue found in audits, inspections- Give regular feedback on QA findings to relvant staffs.- Experience to lead country systems audit (GCP and PV combined) with excellen result- Experiend to set up local training matrix and manual according to SOPs and local regulation Show less

R&D Unit

Korea

R&D Unit

Korea