- 无工作经验
- 招1人
- 11-09 发布
职位描述
职位描述: Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.Job responsibilities include: As a Clinical Affairs Scientist, your main responsibilities will be to determine clinical strategy in conjunction with team members, write clinical study protocols, analyze data and write reports to support the clinical documentation of Clinical Diagnostic studies conducted in China for China approval. The successful candidate has knowledge of China clinical regulatory requirements, experience in designing IVD clinical study protocols, strong background in science and data analysis. This position will also require coordination with internal colleagues, and external partners such as Clinical Research Organizations (CRO), test laboratories and Ethical Committees in hospitals. Measurement of success includes:Ability to contribute to the clinical strategy for IVD clinical studies being conducted in China both for China approval and globally Ability to write and interpret clinical protocols, reports and provide data analysisAbility to provide leadership and direction to the clinical affairs scientific staffAbility to communicate and work with international teams; good English skills, written and oral, requiredAbility & experience to work in a fast-moving, self-driven teamQualifications:* University degree in pharmaceutical, medical or other relevant biological science, preferably, advanced degree * Minimum 8 years' experience in clinical studies for diagnostic, medical device, including authoring protocols and reports* A solid knowledge of clinical study design, biostatistics and Good Clinical Practice* Knowledge of clinical diagnostic and/or pathology is preferred.* Experience in working in parallel projects teams* High work capacity may be required at certain times in high priority projects* Advanced skills in both written and spoken communication 职能类别: 生物工程/生物制药
联系方式
公司信息
Agilent is a leader in life sciences, diagnostics and applied chemical markets. The company provides laboratories worldwide with instruments, services, consumables, applications and expertise, enabling customers to gain the insights they seek. Agilent’s expertise and trusted collaboration give them the highest confidence in our solutions. Agilent focuses its expertise on six key markets, where we help our customers achieve their goals: Food: Agilent helps ensure that our global food supply is free of contaminants—whether chemical, viral, bacterial or microbiological. Our customers include government regulators and labs that control food safety, as well as private companies that produce, package and sell food to the public. Environmental and Forensics: From pesticides to pharmaceutical residues to trace metals, we provide fast, accurate and sensitive methods for monitoring contaminants affecting quality of life. Agilent solutions also play an important role in law enforcement by providing robust tools and instruments to analyze and verify evidence at trial, and keeping the world’s top-performing athletes honest. Pharmaceutical: Agilent has one of the broadest solutions portfolios of any company serving the pharmaceutical industry. Our solutions provide precise answers for every segment of the pharmaceutical industry, from disease research and drug discovery to drug development, manufacturing and quality control. The start-to-finish solution set means customers can get products to market faster. Customers trust us to help them test the purity of their therapeutics. Agilent also ensures that their instruments and processes conform to the highest compliance regulations. Diagnostics: Agilent gives doctors a head start in the fight against cancer and other diseases. Our solutions help pathology laboratories deliver fast, accurate information to the doctors, hospitals and medical centers they serve. We help medical professionals make more accurate diagnoses so patients can receive the most effective therapies. Chemical and Energy: The world runs on energy, and energy companies need to locate, extract and refine fuels efficiently and cost-effectively. Our solutions help customers maximize their production and predict failures in their refineries before they happen. Agilent also helps energy researchers investigate biofuels, renewable fuels and other forms of alternate energy. Research: Most life sciences and diagnostics research is done at top-tier universities, with funding from governments around the world. Agilent is helping these researchers learn more about cancer, cardiovascular diseases, diabetes, Alzheimer’s, Parkinson’s, autism and other ailments. Our instruments, software and sample preparation solutions help scientists conduct faster, more accurate research. AGILENT RESEARCH LABORATORIES The purpose of Agilent Research Laboratories is to power Agilent’s growth through breakthrough science and technology. To complement our product line R&D, Agilent Labs looks beyond the evolution of current products and platforms to create the technologies that will underlie tomorrow’s breakthroughs, enabling Agilent customers to answer questions at the leading edge of life science, diagnostics and the applied markets. Our horizon is broad, encompassing synergies across Agilent and seeding new businesses to create competitive differentiation and compelling value for current and future customers and shareholders. To accomplish these goals, we attract and retain top technical talent, collaborate extensively with global research leaders in academia, government and industry, and promote a culture of innovation and teamwork across our highly multi-disciplinary staff of life scientists, physical scientists and engineers. The majority of our research is located in the United States in Santa Clara, California, with additional locations in Europe and Asia.
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