ISS Specialist/±Û·Î¹ú¿Ü±¹°èÁ¦¾àȸ»ç
±Û·Î¹ú¿Ü±¹°èÁ¦¾àȸ»ç¿¡¼ ISS Specialist¸¦ ã°í °è½Ê´Ï´Ù.
ISS´Â Investigator Sponsored StudyÀ̸ç, ESR(Externally Sponsored Scientific Research) ȤÀº IIT(Investigator Initiated Trial) ¶ó°í Ç¥ÇöÇϱ⵵ ÇÕ´Ï´Ù.
ÁÖ¾÷¹«´Â ¿ÜºÎ±â°ü(±¹°¡¿¬±¸¼Ò ¹× ´ëÇבּ¸¼Òµî)ÀÇ ¿¬±¸ÀÚÁÖµµÀÓ»ó½ºÅ͵𸦠CoordinationÇÏ´Â ¾÷¹«ÀÔ´Ï´Ù.
ÇöÀç´Â °è¾àÁ÷(»êÈÞ´ëüÁ÷)À¸·Î ã°í °è½Ã¸ç, ±Ù¹«±â°£Àº 2016³â 9¿ù±îÁö ÀÔ´Ï´Ù.(¿ÃÇØ 8¿ù¿¡ ÀÔ»çÇϽŴٸé, ¾à 1³â 2°³¿ù ¿©ÀÇ ¾÷¹«±â°£ÀÔ´Ï´Ù.)
[Responsibilities]
- Executes effective planning, implementation, monitoring, management and reporting of ESR(Externally Sponsored Scientific Research)s , such that the research meets all the company, ICH GCP and local requirements, in accordance with quality standards and agreed resource, budget, timelines and publication plan.
- Reports medical projects in all applicable databases
- Instructs the investigators how to use ES2ROS (Externally Sponsored Scientific Research Operations System) database
- Organises LREG(Local Review and Evaluation Group) meetings
- Communicates with the GREG(Global Review and Evaluation Group) members
- Communicates with CRO(Contract Research Organization)s/investigators regarding the project execution status
- Prepares agreements with CROs/institutions/investigators/External Service Providers.
- Prepares applicable tracking reports for medical projects
[Requirements]
- Á¤±Ô´ëÁ¹ ÀÌ»óÀÚ·Î ¾àÇÐ,°£È£ÇÐ,»ý¸í°øÇÐ µî °ü·Ã Çаú Àü°øÀÚ ¼±È£
- 1³â ÀÌ»ó Clinical research, NIS, PMS °ü·Ã ¾÷¹«ÀÚ, MSL °æ·ÂÀÚ¿ì´ë
- Administrative experience, preferably in the pharmaceutical sector
- Good verbal & written communication skills (at least Intermediate level of English)
- Good knowledge of ICH-GCP guidelines
- Good understanding of the Clinical Study Process
´ã´çÀÚ : (ÁÖ)¸¶ÀϽºÅæ¼Ä¡ (www.mstone.co.kr) Á¶¼ºÀºÂ÷Àå
¿¬¶ôó : 02-2050-0298, 010-4789-1978
À̸ÞÀÏ : secho@mstone.co.kr
Áö¿ø½Ã Á¦Ãâ¼·ù : ±¹¿µ¹®À̷¼
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