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CRM(Clinical Trials Manager)/¿Ü±¹°è Á¦¾àȸ»ç ÀÓ»ó°æ·ÂÀÚ ¸ðÁý
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CRM/Clinical Trials Manager(Multinational Pharmaceutical Company)
A multinational pharmaceutical company, which is located in Kangnam-gu, is looking for a Clinical Trials Manager who has following qualifications and that will be in chage of following responsibilities
Qualifications:
1. Majored in Pharmacy, Science of Nursing, Clinical Pharmacology, Pharmacodynamics, Pharmacokinetics or related disciplines
2. Holder of pharmacist license(¾à»ç ÀÚ°ÝÁõ ¼ÒÁöÀÚ)
3. More than 5 years of experiences in the clinical research and trials(ÀÓ»ó°æ·Â 5³â ÀÌ»ó)
4. Good command of English is preferred
Responsibilities:
-Develop Investigational Plan
-Develop protocol, ICF(Informed Consent Form) template, and CRFs(Case Report Forms)
-Oversee the Clinical team internally and externally to ensure the successful implementation of clinical initiatives.
-Develop clinical trial timelines.
-Manages clinical trial budgets.
-Manage study vendors; to include oversight of clinical supplies, CRO, data management groups and core laboratories.
-Develop study tools for implementation and tracking of study activities.
-Initiate site selection plan for new clinical trials and investigator sites.
-Communicate with sites and resolve inquiries and problems related to clinical investigation.
-Manage trial enrollment to meet timelines.
-Assist with obtaining required legal, ethical and technical agreements with sites participating in studies.
-Prepare clinical data for internal use, presentations and as needed for regulator submissions. Provide clinical data when needed for presentations, monographs and publications.
-Oversee, review and approve case report forms, investigator qualification reports, site initiation reports, and monitoring reports.
-Plan, organize and participate in investigator meetings, ad hoc scientific advisory board meetings.
-Maintain a high level of professional expertise through familiarity with clinical literature and participation in project meetings.
-Mentor CTSs and CRAs
* Remuneration shall be negotiable in accordance with the qualifications of applicants
* Please send cv in Korean & English to
suchoi@prgconsulting.co.kr
alongwith a photo file as soon as possible.
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02-568-8747
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suchoi@prgconsulting.co.kr
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http://www.prgconsulting.co.kr
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[135-280] ¼¿ï °³²±¸ ´ëÄ¡µ¿ 891-23 ´ë¿ì¾ÆÀ̺ô ¸í¹®°¡ 510È£
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