• 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: Overall management of Clinical Diagnostic studies conducted in China for China approval and monitoring of sites in China and possibly other Asia Pacific sites, participating in global IVD studies. Management responsibilities include planning, communication, coordination and day-to-day operations related to clinical lab sites participating in studies. This includes coordination with internal colleagues, and external partners such as Clinical Research Organizations (CRO), test laboratories and Ethical Committees. The successful candidate has knowledge of China clinical regulatory requirements, experience in managing IVD clinical trials, and ensuring monitoring of studies, data collection and handling. Experience in designing IVD clinical study protocols and managing CRO is preferred. The position may also require the preparation, revision and maintenance of procedures relevant to clinical affairs and the conduct of human studies.Measurement of success includes:*Professionalism in all aspects of interactions and communication skills with internal colleagues, clinical study lab sites and pharmaceutical partners*Ability to communicate and work with international teams; good English skills, written and oral, required.*Ability & experience to work in a fast-moving, self-driven team*Ability to organize and coordinate documentation related to IVD clinical studies being conducted in China both for China approval and globally.Qualifications:*Advanced degree or Bachelor's degree in a biologic discipline with equivalent job experiences required; pathology or IVD experience preferred.*8+ years of Clinical Trial Management experience for medical device, pharmaceutical or biological products; experience in diagnostics preferred*A solid understanding of clinical project management and familiarity with project management tools.*Understand and have experience related to the regulatory requirements of China controlling bodies and framework as regards IVD development.*Knowledge of pathology and/or oncology is necessary*Experience in working in parallel project teams*High work capacity is required at certain times in high priority projects*Experience in CRO/vendor management and contracting is preferred*The ability to organize and motivate others 职能类别: 生物工程/生物制药

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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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