■ 업무개요 ① Manages phase IV studies (both primary and secondary data) including PMS as a Local Project Manager ② Maintains timely and effective communication among cross-functional team members, CRO and site staff. Routinely anticipates/identifies potential issues and implements corrective actions independently. Keeps project leadership apprised of team issues, seeking guidance as needed. Demonstrates effective conflict resolution ③ Responsible for site management and site staff performance including: monitors all types of clinical studies participates in all types of site visits assures compliance with all protocol requirements assures effective patient identification and recruitment plan is in place assures timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations ensures proper storage, dispensation, and accountability of all Investigational Product (if applicable) and study-related materials regularly reviews the status of the contents of the site binder exhibits effective time management skills ④ Organize and attends Investigator meetings. May present materials, as requested. Manages with the preparation of study start-up materials and tools, as requested. Attends medical staff meetings, project team meetings, teleconference with oversea colleagues, and internal/external clinical training sessions according to the project communication, quality review, and/or training plans ⑤ Completes and submits reports according to Bayer SOP or local regulations. Maintains awareness of key study performance indicators for own sites, e.g. Quality Review Visit Reports, patient enrollment, and SAEs. Updates study and patient status information. Tracks Investigator payments/milestones. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit ⑥ Conduct site monitoring (including ICF check, source data verification, CRF/safety reports review, study file review, study drug accountability check) to ensure that studies are going well in accordance with protocol, GCP, relevant guidelines and SOPs. ■ 응시자격
- Bachelor’s Degree of University (or equivalent) - Pharmacist or nurse or major in scientific field is preferred - More than 3-5 years of relevant healthcare experience including project & site management - Experience in PMS and clinical study is preferred - Effective written and verbal English communication skills - Proactive, Interpersonal, decision-making and issue resolution skills are required - Good communication, negotiation and presentation skill - IT skills: Microsoft word/Excel/PowerPoint/Outlook - Comprehensive knowledge of clinical development process and relevant regulations (e.g., GCP, SOP, local regulations) | 
