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A.ÀÓ»ó Medical Monitoring ÀÌ»ç~»ó¹«±Þ

: ÀÇ»ç¸éÇã(MD) º¸À¯ Çʼö, Ç÷¾×Á¾¾çÇÐ ¶Ç´Â ³»°ú Àü¹®ÀÇ ¿ì´ë

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1) Medical Oversight

- Ãʱâ~Èıâ ÀÓ»ó½ÃÇè(Ph I~III, PMS)ÀÇ ÀÇÇÐÀû °ü¸® ¹× °¨µ¶

2) Safety Monitoring

- ÀÌ»ó»ç·Ê(SAE, SUSAR µî) °ËÅä ¹× Æò°¡, ±ÔÁ¦±â°ü º¸°íÁö¿ø

3) Study Design & Conduct Support

- ÇÁ·ÎÅäÄÝ, ICF, CRF µî ÁÖ¿ä¹®¼­ÀÇ ÀÇÇÐÀû °ËÅä ¹× ÀÚ¹®Á¦°ø

4) Data Review & Communication

- ¿¬±¸ µ¥ÀÌÅÍ ÇØ¼® ¹× ÀÇÇÐÀû ÀλçÀÌÆ® Á¦°ø

- ½ºÆù¼­ ¹× ±Û·Î¹ú ÆÀ°úÀÇ ÀÇÇÐ Ä¿¹Â´ÏÄÉÀÌ¼Ç ¹× ȸÀÇ Âü¼®

- ´Ù±¹°¡ ÀÓ»ó (MRCT) Âü¿©

5) Regulatory & Compliance

- GCP/ICH/MFDS µî ±ÔÁ¦ °¡À̵å¶óÀÎ ¹× À±±â ±âÁØ Áؼö °ü¸®

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- ÀÇ»ç¸éÇã (MD) º¸À¯ÀÚ

- ÀÓ»óÁø·á ¶Ç´Â Àӻ󿬱¸ (Trial Investigator, Sub-I, Á¦¾à»ç ¶Ç´Â CRO) °æ·Â 3~5³â ÀÌ»ó

- ÀÓ»ó½ÃÇè ¼³°è, Á¾¾çÇÐ ÀÓ»ó ÁöÇ¥(RECIST, ORR, PFS, OS µî) ¹× ¾ÈÀü¼º Æò°¡ °æÇèÀÚ

- ¿µ¾î, Çѱ¹¾î ÀÇÇй®¼­ ¸®ºä ¹× ¿øÈ°ÇÑ Ä¿¹Â´ÏÄÉÀÌ¼Ç ´É·Â º¸À¯ÀÚ

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- Ç÷¾×Á¾¾çÇÐ Àü°ø ³»°ú Àü¹®ÀÇ

- Ç×¾ÏÁ¦ ÀÓ»ó½ÃÇè ¼öÇà ¶Ç´Â ÀÇÇÐ ¸ð´ÏÅ͸µ (Medical Monitoring) °æÇèÀÚ

B.LPS PM °úÂ÷Àå±Þ 2¸í

- Àüü °æ·Â 7³â ÀÌ»ó, PM °æ·Â 2³â ÀÌ»ó

- LPS(PMS) °úÁ¦ °æÇè Çʼö

 ¾÷¹«³»¿ë

- Project Management

- Site management

- Communication with sponsors

- Site monitoring and ensure quality of monitoring etc.

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- Over 7 years of clinical research experience in pharmaceuticals/CROs

- Over 2 years of project manager experience

- Good knowledge of GCP, regulatory requirements and study conduct

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-Fluent English (verbal and written)

±Ù¹«Áö: ¼­¿ï Á¾·Î±¸ »çÁ÷·Î º»»ç (÷ºÎ ±¹¹® Áö¿ø¼­ Çʼö)

MS-WORDÀ̷¼­¿¡´Â ÃÖÁ¾¿¬ºÀ/Èñ¸Á¿¬ºÀ/Çٽɿª·®/ÀÌÁ÷»çÀ¯/Áö¿ø»çÀ¯µî ±â¼úÀÌ ÇʼöÀÔ´Ï´Ù.

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==>C163-02 ÀÓ»ó½ÃÇè±â°üÀÇ ÀÓ»ó Medical Monitoring ÀÓ¿ø(ÀÇ»ç¸éÇã)±Þ ¹× LPS PM °úÂ÷Àå±Þ 2¸í




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