郑州招聘

Position Summary：

This position is responsible for the study-level management (prior to submitting to IRB/EC to closeout) of clinical studies, including preparation of applicable clinical study documents/plans, oversight of clinical site performance, while ensuring cross-functional teams are appropriately informed and coordinated to execute the clinical study. Responsibilities：

Develop and maintain a working knowledge of local and global regulatory requirements and standards (e.g., FDA CFR, ISO 14155, ICH GCP, EU MDR) that impact clinical studies assigned; Provide vigilance over clinical study and track study progress; work with the appropriate clinical study team members and/or management to ensure study activities are being conducted in a timely manner to achieve study objectives and milestones; comply with the global clinical function quality system procedures/instructions; and provide oversight that the study observes the applicable regulations and standards; Lead efforts to document and train the internal clinical study team, vendor CRAs, and site study team; Lead and manage vendor activities in support of assigned studies (e.g., site initiation, site visits, auditing, e-diaries, and patient recruitment); Develop and maintain a working knowledge of study specific and general disease pathology; Ensure that appropriate resources are available to achieve study objectives and milestones; Develop and coordinate clinical study-related documents, plans, and training materials (e.g., Study Protocol, Informed Consent Template, Monitoring Plan, Risk Management Plan); Maintain effective communication with cross functional teams and stakeholders; Assist in preparation and submission of regulatory applications for the clinical study, where appropriate; Lead efforts, drive the content, and collaborate with the appropriate personnel for external meetings (e.g., RC, Investigator, SIM); Lead efforts and plans for clinical study meetings and preparation of study materials for distribution to clinical sites; Ensure the clinical study is registered and maintained on a public database, if applicable; Participate in site selection and principle investigator changes during the clinical study; Ensure clinical study data within clinical systems (e.g., EDC, CDMS) are accurate and up to date and Participate in clinical function process improvement strategies.

Essential Qualifications

A minimum of a Bachelor’s degree (scientific-, health-, or business-related field preferred) plus significant relevant experience is required; Master’s degree with demonstrated research or project management background is preferred; Previous experience in the conduct of medical device/drug clinical studies (including a knowledge of applicable regulations and standards) is preferred; Ability to exercise sound judgment in independent decision making; Outstanding work ethic and strong personal discipline; Ability to interact with internal and external stakeholders (e.g., study team, physicians, scientists, division representative) in a professional and personable demeanor; Capability to handle multiple projects and responsibilities; Proficient in the following skill sets: time management, leadership, written and verbal communication, problem-solving (e.g., root cause analysis, lean management); Ability and desire to work in a collegial team atmosphere; including communicating and working constructively with colleagues; Sufficiently assertive to deal with confrontational situations; Willingness and ability to travel as needed.

库克医疗（cook medical）
库克公司于1963年创建于美国印第安纳州的bloomington。最初以生产血管介入产品为主，也是最早涉足此领域的公司之一。seldinger法血管穿刺、经皮腔内血管成形术等日后对介入诊断与治疗产生根本性影响的技术的推广与普及背后，都有库克公司的卓越贡献。

从建立之初，库克公司便奉行“服务患者，着眼未来”的宗旨，通过自主研发以及与全球***科研机构、医院及专家的合作，不断推出更多创新性医疗产品，服务于患者健康。始终保持在微创诊断与治疗领域的领先地位。

如今，库克公司已发展成为全球规模***的私人医疗器械公司（private company），形成以医疗器械研发与生产为核心，并涉足生物制药、基因与细胞疗法以及生物科技领域的产销一体化跨国集团公司。公司在美国、欧洲和澳大利亚等地设有9大医疗器械生产及研发中心，并在全球主要国家与地区均设有分支机构。产品线也从最初的血管介入迅速扩展，目前主要涉及主动脉介入、心脏介入、急诊医学、消化病学、放射学、外周血管介入、骨穿刺与肿瘤学、外科与软组织修复、泌尿科学以及辅助生殖技术、妇科及产科学等领域，并在多个学科处于领先地位。

库克（中国）医疗贸易有限公司
cook (china) medical trading co., ltd.
库克公司于1996年开始进入中国市场，依托强大的研发和品牌实力，迅速成为最受医生欢迎的品牌之一。2008年，库克公司投资5000万人民币，在上海成立全资子公司——库克（中国）医疗贸易有限公司，以满足国内及亚洲地区迅速增长的医疗器械市场需求。新建于上海外高桥保税区的配送中心占地面积将分期扩充至3500平方米；占地600平方米的客服中心位于上海市区，将负责处理来自我国大陆、香港、台湾，以及韩国、日本、新加坡、马来西亚、印度、菲律宾、泰国、印度尼西亚、柬埔寨、越南等地的订单需求。

如今的库克中国集仓储、物流、配送、客服及销售等各项职能于一体，将作为一个位于上海、面向亚洲医疗器械市场的区域共享服务中心，服务于国内及亚洲市场。

公司主业：www.cookmedical.com

公司网站：http://www.cookmedical.com

联 系 人：grace wang

地 址：北京市朝阳区东三环中路1号环球金融中心东塔1210

邮政编码：100022