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2年经验 -
本科 -
招1人 -
11-09 发布
职位描述
职位描述： Position Description:?Maintain and assist in preparation of clinical study files in accordance with Medtronic requirements as well as Good Clinical Practices?Assists in organizing, scheduling and conducting clinical project review meetings and is responsible for publishing minutes and action items?Responsible for study payments?Follow up and track clinical contract and other legal document execution?Maintain study and investigator databasesPosition Responsibilities:?Maintain and assist in preparation of clinical study files in accordance with Medtronic requirements as well as Good Clinical Practices?Responsible for the scheduling, conduct, minutes and action items for Project Review minutes. Assists the study lead in preparation of meetings. Assist in publishing project action-items. Assists the study lead in reviewing meeting minutes, which will include tracking deliverables and open items.?Responsible for study payments?Follow up and track clinical contract and other legal document execution?Centralizes and maintains critical project information?Responsible for consolidating project and pipeline reports using templates?Support project teams with project coordination as needed?Provides summary reports for internal stakeholders and project review meetings.?Maintains databases for investigator contact information, performance, site nominations, and study participation. Compiles top level study information from study leads and issues weekly reports to cross function stakeholders.?Implements improvements to tools and templates?Responsible for managing the library of tools and templates for projects and clinical studies.?Coordinate the timely order of clinical supplies and ensure their receipt by study sites.?Assists with medical literature research?Performs other duties as assigned.RequirementsEducationAt minimum, a Bachelor degree in Life Sciences or other technical disciplineSkills, Knowledge and ExperienceBasic clinical research knowledge and cross-functional understanding of clinical trial methodology and executionA minimum of 2-year experience in clinical study assistance and coordinationBasic understanding of International Conference on Harmonization (ICH), Good Clinical Practices (GCP), ISO 14155 2011, safety and data management requirements, clinical trials management, regulatory compliance (including individual global/country directives/regulations as necessary) and reportingAdvanced knowledge of Microsoft Office including Excel, Project, Access, Powerpoint, and WordAbility to communicate (speaking and writing) clearly and effectively in EnglishHighly developed attention to detail and tracking skills to ensure quality data collection, evaluation and reportingAbility to work with a relentless focus on quality, efficiency and ongoing improvementStrong prioritization and organizational skillsAccountable, proactive, flexible and dependableTravel up to 15% 职能类别： 临床研究员 临床数据分析员 关键字： 临床项目助理 临床研究员
联系方式
上海
公司信息
医疗科技生命所系 美敦力是一家在全球居于领先地位的医疗技术公司，致力于为慢性病患者提供终身的解决方案。在过去的岁月里，美敦力已经为专业医务人员提供了医疗产品及治疗方案，每年帮助逾500万的患者改善了生活品质。美敦力的主要产品覆盖了以下领域：心脏起搏治疗，心律失常管理，冠脉和周围血管疾病等方面。公司多次被《财富》杂志评为100家最值得赞赏的公司之一，并位于该行业前列。同时，在《财富》杂志“100家***雇主”上榜上有名。 因美敦力在中国的业务飞速发展，现诚聘人员，欢迎符合条件的优秀专业人才加入。 美敦力公司为员工提供具有竞争力的薪资福利，完善的培训与职业发展计划。敬请有志人士在2周内准备中英文简历、近照及证件、证书复印件寄往本公司。（请在信封上注明申请岗位、业务种类及工作地点） 非中介不收费。
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