上海相关职位： 技术员-上海 高级销售代表（口腔医疗器械）上海地区 医药代表-糖尿病健康产品 医疗器械销售代表 工艺试制工程师 创新药制剂研究员（2018校招）（上海张江）J10939 高级项目经理 医学事务部之高级医学经理 临床研究助理-药物临床研究 临床监察员-CRA-上市后药物临床试验（四期）
周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期： 2017-11-09
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无工作经验 -
招若干人 -
11-09 发布
- 五险一金
- 补充医疗保险
- 补充公积金
- 交通补贴
- 餐饮补贴
- 通讯补贴
- 绩效奖金
职位描述
职位描述： PURPOSEObtain and process adverse event (AE) data obtained in clinical trials and spontaneous reports according to applicableregulations and guidelines, standard operating procedures (SOPs), and project requirements. Lead small (up to andocassionally greater than 100 AEs) clinical, Clinical Event Validation and Adjudication (CEVA) or post-marketing safetyprojects ensuring all activities are completed on time, within budget and meet quality standards.RESPONSIBILITIES? Receive and document incoming telephone calls or faxes from investigative sites or other sources reporting AEs, seriousadverse events (SAEs) and spontaneous events; collect, track required data and enter into safety database, if applicable;follow up with sites to obtain missing data as required. Process data according to applicable regulations and guidelines,SOPs, and project requirements.? Triage and classify incoming events; prioritze event case according to regulatory and project requirements.? Ensure integrity and completeness of data according to applicable regulations and guidelines, SOPs and project-specificguidelines.? Create complete, accurate and succinct narratives adhering to established project template. Establish and maintain athorough understanding of project protocol, budget and scope of work (SOW) for assigned projects; set up and maintainproject materials such as project files, forms, templates, databases and workflow.? Establish and maintain effective project communications by representing department at interdepartmental project teammeetings, investigator meetings, and client meetings and by conducting productive internal department project teammeetings.? Track financial status of assigned projects; assist Project Manager with clinical safety-related change orders.? Provide regular reports to overall project manager and department management on project metrics, SOW changes, clientrequests or concerns; communicate and document project issues to project team members and departmentmanagement in a timely manner; with guidance, complete regulatory reports.? Mentor less experienced/new staff membersREQUIRED KNOWLEDGE, SKILLS AND ABILITIES? Working knowledge of AE processing, CEVA and Post Marketing requirements? Working knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good ClinicalPractice (GCP) and International Conference on Harmonisation (ICH) guidelines? In-depth knowledge of departmental SOPs? Strong organizational skills with the ability to meet strict deadlines? Skill in use of multiple safety databases? Basic project management skills? Demonstrate a positive and flexible working attitude? Effective presentation and report writing skills? Effective team building skillsJOB DESCRIPTION? Effective telephone etiquette skills? Excellent verbal and written communication skills? Ability to work effectively on multiple projects simultaneously and effectively manage competing priorities? Ability to establish and maintain effective working relationships with coworkers, managers and clients 职能类别： 临床数据分析员
联系方式
枫林路388号枫林国际大厦A座3楼
公司信息
QuintilesIMS pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you.
