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更新于 5月12日

臨床運營經理

2.5-4萬
  • 北京昌平區(qū)
  • 經驗不限
  • 本科
  • 全職
  • 招1人

職位描述

臨床監(jiān)查員臨床協(xié)調項目管理CRO
Responsiblities ??? Facilitate to identify and select trial vendors, including but not limited to CROs, Labs, SMOs for clinical studies together with other stakeholders. Negotiate the quotation and contract. ???Require, manage and coordinate the study resource internally and externally. ???Set-up and/or lead the study team (internal & external) to set up and review study plans including timeline, trial supplies, essential documents and all other plans (project management plan, monitoring plan, training plan, and etc.) properly. ???Oversee and manage the clinical operational activities with CROs, third-party vendors, consultants and internal personnel to execute clinical studies to ensure that the studies proceed according to the plans ???Oversee study start-up, conduct and close-out activities, including site feasibility ???Oversee clinical site monitoring activities and review/approve monitoring visit reports. ???Oversee the trial quality by conducting co-monitoring visits, lead risk & issue identification and resolution, and other related quality activities ???Manage CRO, third-party vendors and consultant’s work, including review and approval of scope of work, contract, budget and invoices ???Develop collaborative relationships with internal partners, external organizations, key opinion leaders, and investigators ???Collaborate with CRO study directors and project managers to foresee and solve problems ???Consult and coordinate with the internal medical team, drug supply team and external consultants regarding the design and conduct of studies Qualifications ???Bachelor’s degree or master’s degree in a medicine-related discipline. ???At least 5 years of working experience including 1.5-3 years of clinical operations project management experience. ???Experience with clinical studies in Australia or US is a plus. ???Knowledge of the relevant drug development process including project and site management, local and international regulations, ICH-GCP, drug safety requirements, data management processes, budget and vendor management and other functions or industry knowledges. ???Ability to travel extensively within country and rarely for Intercontinental trave as well. ???Excellent communication skills. ???Fluent written and spoken English, and proficiency in Chinese is a plus (for abroad candidates only). ???Ability to handle high volume of work and tight deadlines. ???Proficiency in MS Office, including Word, Excel, and PowerPoint.

工作地點

昌平區(qū)北京炎明生物科技有限公司

職位發(fā)布者

張婧/人事經理

三日內活躍
立即溝通
公司Logo北京炎明生物科技有限公司
北京炎明生物科技有限公司(Pyrotech Therapeutic)于2020年底成立,總部位于北京中關村生命科學園,擁有4000平米的研發(fā)總部和新藥研發(fā)團隊,美國研發(fā)中心也正在計劃籌建中。目前,炎明生物已開展多個針對細胞焦亡/天然免疫靶點的新藥研發(fā)項目,并獲得了中國知名投資機構以及政府的大力支持。
公司主頁
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