更新于 今天

MA Manager (MJ001252)-全國-非腫瘤

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

職位描述

藥物研究內科
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

武漢武昌區平安金融科技大廈

職位發布者

展迪/人事經理

昨日活躍
立即溝通
公司Logo昆翎(北京)醫藥科技發展有限公司
昆翎(ClinChoice)是一家致力于為生物醫藥和醫療器械客戶提供高品質一站式服務的臨床階段CRO,服務包括臨床運營、項目管理、生物統計、數據管理、注冊事務、醫學事務和藥物警戒。昆翎已經在中國、美國、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,其臨床運營團隊覆蓋了亞、歐、北美等七個國家和地區。高盛直投部董事總經理、昆翎董事會成員許小鷗先生認為,“隨著創新療法在全球的增長,CRO公司提供高效、可靠的研發服務能力變得尤其重要。昆翎獨特的價值主張結合了其對于本地市場的了解、國際藥物研發的經驗以及高效的團隊執行能力。我們堅信公司強勁的管理層團隊以及其高效的執行能力,將為昆翎的發展開啟新的篇章。
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