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[´ã´ç¾÷¹«] 1. ÀÓ»óPM(Â÷~ºÎÀå) / À¯¸Á¹ÙÀÌ¿À±â¾÷ (¼¿ï °ºÏ±Ç) - Clinical operation direct managing & site oversight - Vendor(DM, STAT, logistics µî) communication ¹× oversight - Preparation of study manuals ¹× ÀÓ»ó ¹®¼°ü¸® - SOP Àç/°³Á¤ ¹× Project documents ÀÛ¼º ¹× °ü¸® - PM°æ·Â 3³â ÀÌ»ó Æ÷ÇÔ ÀÓ»ó °æ·Â 8³â ~ 15³â - Global study management °æ·Â (set-up to closing) - SOP ÀÛ¼º, °ü¸®, Audit µî ¼öÇà °æ·ÂÀÚ - ÇØ¿ÜÃâÀå °¡´ÉÀÚ ¹× Business¿µ¾î °¡´ÉÀÚ 2. Clinical Research Manager / ±¹³»CRO - Àη ¿î¿µ °èȹ ¼ö¸³, Á÷¿ø ¹èÄ¡, ¾÷¹« ÇÒ´ç, ǰÁú °ü¸® - LMÀ¸·Î¼ Workload, Quality, Performance Æò°¡ ¹× °ü¸® - ¿Âº¸µù(On-boarding) ±³À° ¹× Á÷¹« ±³À° Á¦°ø - CRA ´ë»ó Visit ¼öÇà(Observation, Training, Sign-off, QC) - ÃÖ¼Ò 10³â ÀÌ»óÀÇ ÀÓ»ó½ÃÇè(Clinical Research) °æ·Â º¸À¯ÀÚ - ÃÖ¼Ò 2³â ÀÌ»óÀÇ ÆÀ °ü¸®(Team Management) °æÇè Çʼö 3. ÀÓ»óÀü·« ºÎ¼Àå(MD) / ±¹³»CRO - Management for Clinical Strategy (CS) Department - Set Business plan for CS department - Overall management and review for project conducted by CS - Clinical strategy consulting and Education for CS department - Overall management for clients and stakeholders - Minimum of 5 years in clinical medicine, clinical research - Good command of spoken and written English - Experience as director of medical affairs 4. ÀÓ»óPM(½ÅÀÔ1¸í, °æ·Â1¸í) / ±¹³»CRO *½ÅÀÔPM - Overall Project management - Lead CRA Æ÷ÇÔ CRA °æ·Â 5³â ÀÌ»ó *°æ·ÂPM - Overall Project management - PM°æ·Â 3³â ÀÌ»ó 5. ÀÓ»óÅë°è / ±¹³»CRO - Statistical Analysis - Statistical/CDISC Programming - Study design (Sample size calculation, Protocol (statistical section) - ¼®»ç ÀÌ»ó ¹× ÀÓ»ó Åë°èºÐ¼® ¶Ç´Â SAS Programming °æ·Â 5³â ÀÌ»ó 6. ÀÓ»óDBA(CDPÆÀ) / ±¹³»CRO - SAS Programming for data validation, data reconciliation - Study Database Maintenance - ÀÓ»óDM °æ·Â 2³â ÀÌ»ó 10³â ÀÌÇÏ - SAS Programming (Data Handling) °æ·Â 1³â ÀÌ»ó - ÀÓ»óµ¥ÀÌÅͰü¸®½Ã½ºÅÛ(CRScube ¶Ç´Â Medidata) Builder °æÇè(¿ì´ë) - SAS ¿Ü Python, R µî Programming ¾ð¾î Ȱ¿ë °¡´É(¿ì´ë) - ¿µ¾î ¹®¼ ÀÛ¼º ¹× Ä¿¹Â´ÏÄÉÀÌ¼Ç °¡´É(¿ì´ë) 7. ÀÓ»óDBA(DBMÆÀ) / ±¹³»CRO - EDC System Build & Configuration ¼öÇà - Study Datatbase Maintenance - EDC System Builder °æ·Â 2³â ~10³â - Medidata Rave Builder °æÇèÀÚ - SAS µî Data handling °æÇèÀÚ - ¿µ¾î Ä¿¹Â´ÏÄÉÀÌ¼Ç °¡´ÉÀÚ(¿ì´ë)
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