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更新于 6月17日

MA Manager (MJ001252)-全國(guó)-非腫瘤

2-3萬(wàn)
  • 武漢武昌區(qū)
  • 3-5年
  • 碩士
  • 全職
  • 招1人

職位描述

藥物研究內(nèi)科
Participate in all stages of the clinical trial development process including: feasibility assessments;protocol design; CRF design; investigational site selection; generation of clinical study reports ? Acts as Medical Monitor / Advisor for assigned trials or programmes ? Exhibit and transmit the highest ethical standards in the management of clinical trial programs and client liaison ? Provide medical support to the clinical project teams ? Provide therapeutic area training to the clinical project teams and investigator teams ? Take responsibility for the medical management of adverse events and serious adverse events in accordance with project related guidance ? Review SAE narratives and takes responsibility for the writing of narratives associated with critical events as defined by each project ? Oversee medical aspects of the risk management and risk mitigation strategies ? Supports Pharmacovigilance is relevant steps of case processing and periodic reporting ? Provide medical input to relevant Pharmacovigilance activities throughout the product lifecycle ? Take responsibility for and initiates the medical review of: protocols; CRFs; adverse events; clinical study reports; data management and statistical tables and listings; audit reports ? Write assigned sections of clinical study reports post graduate medical qualifications with a licence to practice medicine in china ? Ideally qualified with Master in clinical medicine ? 3 or more years of practising clinical medicine ? 3 or more years of clinical research/development experience within a pharmaceutical or biotechnology company or clinical research organisation ? Comprehensive knowledge of the clinical development process and its critical paths ? Extensive knowledge of ICH GCP, China GCP ? Awareness of China regulatory and pharmacovigilance environments ? Experience of a wide breadth of therapeutic areas

工作地點(diǎn)

武漢武昌區(qū)平安金融科技大廈

職位發(fā)布者

展迪/人事經(jīng)理

昨日活躍
立即溝通
公司Logo昆翎(北京)醫(yī)藥科技發(fā)展有限公司
昆翎(ClinChoice)是一家致力于為生物醫(yī)藥和醫(yī)療器械客戶提供高品質(zhì)一站式服務(wù)的臨床階段CRO,服務(wù)包括臨床運(yùn)營(yíng)、項(xiàng)目管理、生物統(tǒng)計(jì)、數(shù)據(jù)管理、注冊(cè)事務(wù)、醫(yī)學(xué)事務(wù)和藥物警戒。昆翎已經(jīng)在中國(guó)、美國(guó)、歐洲、印度、日本和菲律賓建立了主要的臨床交付中心,目前在全球擁有1800多名員工,其臨床運(yùn)營(yíng)團(tuán)隊(duì)覆蓋了亞、歐、北美等七個(gè)國(guó)家和地區(qū)。高盛直投部董事總經(jīng)理、昆翎董事會(huì)成員許小鷗先生認(rèn)為,“隨著創(chuàng)新療法在全球的增長(zhǎng),CRO公司提供高效、可靠的研發(fā)服務(wù)能力變得尤其重要。昆翎獨(dú)特的價(jià)值主張結(jié)合了其對(duì)于本地市場(chǎng)的了解、國(guó)際藥物研發(fā)的經(jīng)驗(yàn)以及高效的團(tuán)隊(duì)執(zhí)行能力。我們堅(jiān)信公司強(qiáng)勁的管理層團(tuán)隊(duì)以及其高效的執(zhí)行能力,將為昆翎的發(fā)展開(kāi)啟新的篇章。
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