北京招聘

职位描述：
Searching for an experienced Clinical Trial Manager to work within the Companion Diagnostics team of Dako North America & Dako China, both Agilent Technology Companies.
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 test laboratories and Ethical Committees. The successful candidate has knowledge of China clinical regulatory requirements, experience in managing clinical trials, and ensuring monitoring of studies, data collection and handling. Experience in managing Clinical Research Organizations (CRO) is not required but preferred. Experience in designing IVD clinical protocols and managing IVD studies is preferred but not required. 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 with international teams; good English-language skills, both written and oral, is required
* Ability & experience to work in a fast-moving, self-driven team
* Ability to organize and coordinate documentation related to clinical IVD studies being conducted in China both for China approval and globally.
* Advanced degree or Bachelor of Science degree with equivalent job experiences
* 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 requirements of China controlling bodies and framework
* 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
* Flair, enthusiasm and leadership capability when faced with project and professional challenges

Agilent is an Equal Opportunity Employer
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