临床项目专员/Project Specialist招聘_盈帆达医药咨询（上海）有限公司最新招聘信息-猎才医药网

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Essential Job Functions:1. Project Administration - Utilizes designated clinical trial management system to track and process clinical trial information, (e.g., regulatory documents, enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, supplies, Institutional Review Board re-approvals, data queries) in order to provide analysis of information to PM. Processes and tracks vendor invoices, site invoices, and investigator grants payments on assigned projects. Supports assigned PM with initiating requests to Finance Department to generate customer invoices for project labor and expenses. Oversees regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. May conduct secondary review of Essential Regulatory Documents. May serve as project representative for internal and external TMF audits. May serve as in-house site contact for collection of non-essential regulatory documents, tracking and maintaining drug/study supplies, query resolution, administrative protocol and study related questions. Assists the PM with projection and validation of financial backlog and project realization on assigned projects. Includes review of regular financial reports and analysis of upcoming project events to verify financial forecasts. Assists in the development of Informed Consent Form using project specific knowledge and performs in-house Case Report Form review. 2. Reporting - Records the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from the assigned PM. Assesses and communicates KPIs for associated job tasks to PM with proposed action plan. Prepares and provides status reports to customers with oversight from assigned PM. 3. Communication - Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. Schedules and attends internal and external team meetings. May lead internal team meetings and portions of external team meetings as directed by assigned PM. Prepares and distributes all meetings minutes for both internal and external meetings. Follows-up with team members on action items from meetings. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, project management, monitoring, and/or training plans. Prepares for and attends Investigator Meetings, Kick-Off Meetings, Quick Start Camps, and Quality Finish Camps. 4. Training- May train new employees assigned to project.5. Project Leadership - May serve as primary customer contact when PM is out of the office. Seeks input from Project Director for customer support.Other Responsibilities: Acts as Administrator of shared workspace for assigned projects. Performs other work related duties as assigned. Minimal travel may be required (up to 25%). Note: If there are additional responsibilities that are specific to an individual employee, department, country, or other grouping, please use the Job Description Addendum Template.Requirements:BA/BS in the science/healthcare field, nursing degree, or equivalent combination of education and experience. Minimal clinical research experience. Some experience in a company therapeutic group preferred, with demonstrated leadership skills and effective customer interaction. Basic understanding and knowledge of ongoing protocol and disease related terminology, FDA regulations, GCP/ICH guidelines, drug development process for assigned study, as well as company and sponsor SOPs and WIs. Exceptional attention to detail, organizational, interpersonal, and communication skills with demonstration of critical thinking and problem solving skills. Advanced proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), web-based systems, email, and voicemail. Ability to perform several tasks simultaneously to meet deadlines. Self-motivation and ability to work independently. Ability to assist in establishing and maintaining standards, system integrity, and ensuring quality assurance measurements. 职能类别：临床研究员

公司信息

InVentiv Health通过分布在全球70多个国家的14000名员工，为医药、医疗器械和生物工程客户提供临床研发、销售及商务咨询服务，inVentiv Health的目标是通过自身的专业服务将客户的商业理念真正地转化为现实，帮助客户提升业绩，现在inVentiv Health服务于约550家客户的850个品牌。 2011年12月，inVentiv Health在中国设立盈帆达医药咨询（上海）有限公司，正式在中国区域为医药行业客户提供服务。 inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bio-analytical services, and strategic resourcing from a single clinical professional to an entire functional team.

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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