胡女士
2天前在线
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- 职位介绍
- 临床试验
- 临床项目管理
- 新药
- 临床质量管理
- 临床前期
- 临床运营管理
- Location: Shanghai Job Type: Onsite, Full-time employee Reporting to: CSO Job Purpose: Lead execution of local or global clinical studies within budget and in accordance with established timelines and quality standards. Responsibilities: -Builds a high efficient clinical operation team -Ensures clinical trial projects are properly resourced, managed and executed. -Plans and executes project management activities for assigned studies including timelines, risk assessment, mitigation plans, recruitment proposal and plan，and other aspects of clinical study project management (e.g. budget, metrics). -Key document preparation and review (protocols, IBs, CSRs, etc). -Leads study team meetings with internal cross functions and external vendors. -Ensures clinical study sites activation within agreed timeframe. - Timely identifies trends and issues within/across assigned trial(s) which may impact key deliverables (e.g. timelines/quality/costs) and implement action plans to either resolve and/or mitigate those. -Manages clinical study teams/CRO to ensure the trials can be completed on time, within budget and in compliance with regulations. -Designes, updates and implements appropriate procedures related to clinical study development. -Develops study training and may also coordinate/deliver training, as appropriate. -Obtains clinical trial cost forecasts. Establishes and monitors the trial budget. -Maintains and archives at trial level documentation. Qualifications: -Education: Master or doctoral degree in Medicine, Pharmacy, Biology, Immunology，or a related field. -At least 7 years of experience in the pharmaceutical industry, at least 5 years direct experience in planning and managing clinical trials. -The candidate should have significant experience with responsible roles in the conduct or management of Phase I and II clinical trials. -Fluency in English and Chinese language (written and spoken) as well as strong communication skills. -The candidate should be goal-oriented, a self-starter and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment. - Serves as best practice resource within clinical operation; may also act as a technical expert on cross-functional teams or projects.
- 其他信息
- 语言要求：英语、普通话
- 所属部门：临床部
公司简介
上海轶诺药业-kaiyunI体育官网网页登录入口-ios/安卓/手机版app下载是专业从事创新药物研发的制药企业，公司定位于创新药物研发，挑战中国人群高发的重大复杂疾病如免疫性疾病、慢性炎症、代谢性疾病和肿瘤等。以“为患者提供最大的治疗价值”为己任，坚持源头创新，立足自主研发。公司结合国内新药研发现状，借鉴国外跨国制药企业新药研发优势，规划并形成了符合国际研发标准、可持续发展的新药研发创新体系，搭建了包括药物设计合成、体外活性评价、体内药效评价、生物信息学等核心技术平台。
公司目前已经集聚了一批具有丰富药物研发经验的人才，其中50%的员工具有国际大公司背景，约40%的员工具有博士学位。
“良士择木而栖”，期待更多的有识之士加入我们！
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