업무개요
1. Manages a clinical study from planning through to study close within a given frame approved by the Medical Affairs Responsible (MAR) in terms of costs, quality, time and within the standards set for Global Development and local guidelines. 2. Plan studies in order to ensure that the studies are implemented in accordance with protocol, GCP, relevant guidelines and SOPs by preparing required documents such as protocol, case report form (CRF), Informed consent form (ICF), and study supplies including investigational product (IP). 3. Organize investigators meeting, steering committee meeting and site initiation meetings so that study staff are well trained and familiar to study procedures as well as protocol. 4. KFDA and/or IRB submission supported by Medical Project Assistant (MPA) and follow up till getting approvals so that studies are going well on schedule in terms of timelines and comply with GCP, SOPs and local guidelines 5. Conduct site monitoring (including ICF check, source data verification, CRF/safety reports review, study file review, IP accountability check) to ensure that studies are going well in accordance with protocol, GCP, relevant guidelines and SOPs. 6. On going reports and/or communication with KFDA/IRB/investigators and global/country study team, marketing/sales depts. to update and share study progress, protocol, safety and other issues when necessary, and submit annual, bi-annual report to KFDA in order to meet local requirements. 7. Identify tasks to be delegated and select/manage external supplier (ES) and track the progress of delegated tasks so that studies could be conducted in an efficient manner in terms of costs, time, and quality. 8. Comply with pharmaceutical regulations and BHC ethical business practices.
응시자격
- University graduate - Pharmacist or nurse or major in scientific field is preferred - Experience in PMS and clinical trial is preferred - Good command of English - Good communication, negotiation and presentation skill - IT skills : Microsoft word/Excel/PowerPoint - Comprehensive knowledge of clinical development process and relevant regulations (e.g., GCP, SOP, local regulations) |