Drug Safety Associate Manager/药物安全警戒项目经理 上海

月薪： 1-1.5万/月

该公司所有职位
  • 无工作经验
  • 招若干人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 餐饮补贴
  • 通讯补贴
  • 补充公积金
  • 交通补贴
  • 绩效奖金

职位描述

职位描述： PURPOSELead large (over 500 adverse events (AEs)/endpoints) and/or multiple global clinical or post marketing projects ensuring allactivities are completed on-time, within budget and meet quality standards. Obtain and process AE/ICSR/endpoint dataobtained in clinical trials or post marketing projects according to applicable regulations and guidelines, standard operatingprocedures (SOPs), and project requirements.RESPONSIBILITIES? Establish and maintain a thorough understanding of project protocol, budget and scope of work (SOW) for assignedprojects; set up and maintain project materials such as project files, forms, templates, databases and workflow.? Build a positive, collaborative team environment with project team members; provide training and mentoring for projectteam members and department staff; assist management with allocating resources to projects.? 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; provide global coordination of departmental activities.? Participate in client and internal audits for assigned projects. Liaise with Quality Assurance staff and overall managementin the compilation of CAPs.? Track financial status of assigned projects; assist Project Manager with clinical related change orders. Attend andrepresent assigned projects at financial meetings.? Provide comprehensive feedback on project team members for input into appraisals. Provide consistent and frequentfeedback to department managers on staff quality and progression.? Provide regular reports to overall project manager and department management on project metrics, SOW changes, clientrequests or concerns; participate in project review meetings with management; communicate and document projectissues to project team members and department management in a timely manner; complete regulatory reports.? Drive case follow-up and closure processes; process cases as needed.? Assist senior leaders in managing department by identifying, developing and implementing new processes and systemsdesigned to improve quality and efficiency, updating managers on new regulations, representing department at sales,marketing, bid defense and other extra-departmental meetings, creating and modifying SOPs and work instructions(WIs).? Obtain and process adverse event (AE)/ICSR/endpoint data obtained in clinical trials or post marketing projectsaccording to applicable regulations and guidelines, standard operating procedures (SOPs), and project requirements.REQUIRED KNOWLEDGE, SKILLS AND ABILITIES? In-depth knowledge of event processing and Clinical Event Validation and Adjudication in both clinical and postmarketing areas? In-depth 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 standard operating procedures (SOPs)? Skill in use of multiple safety databases? Strong project management skills? Strong coaching skills? Strong team building skills? Excellent written communication skills? Ability to lead projects within strict deadlines? Ability to work effectively on multiple projects simultaneously and effectively manage competing priorities? Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clientsand regulatory agency representatives? 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.

上海相关职位

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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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