Investigator Initiated Research Associate (IIR)招聘_辉瑞（中国）研究开发有限公司最新招聘信息-猎才医药网

职位描述

职位描述：职位描述：Position Purpose? The Investigator Initiated Research (IIR) Associate provides primary support to IIRProgram Managers with necessary communication and coordination to ensureefficient processing of Investigator Initiated Research (IIR) requests.? The IIR Associate is responsible for ensuring study progress including documentmanagement and distribution, ensuring entry of IIR proposals into the system,monitoring proposal status for IIR Program Managers, and securing and enteringstudy closure documentation.Organizational Relationships? Reports into Pfizer Medical, External Medical Communications.? Interact with Therapeutic Area Medical Teams, Finance, Contracts & Outsourcing,Legal, Regulatory, RMRS, Pfizer Country Offices (PCOs), Clinical Supply.Major Duties? Reviews incoming IIR requests and documents for accuracy and completenessand/or enters requests into IIR systems, including uploading and scanning.? Entry of information into the IIR system, acknowledgment communications, andrequests for additional information or documentation through the entire lifecycle ofassigned IIR studies.? Assists PCO colleagues who are completing the IIR submissions in INSPIIRE toaddress missing information and ensures compliance to Pfizer’s policies on SafetyReporting, FCPA, HCP and Privacy.? Manages distribution of documentation, preparation of agendas, and assists withscheduling coordination necessary for Review Committee meetings for IIR programs.? Manages the transactional details of drug supply requests (i.e. generating drugsupply forms) and works with IIR Program Managers and Pharmaceutical SciencesSupply Chain Coordinators to ensure clinical supply forecasts are up-to-date andsupplies are available as required for IIR studies.? Contacts requestors for missing or requested documentation, as directed by IIRProgram Managers.? Prepares required correspondence to IIR requestors and Pfizer colleagues,including acknowledgement letters to requestors and communications to ReviewCommittee members, RMRS, Regional, or PCO colleagues. Works with IIR ProgramManagers to issue correspondence.? Manages distribution of documentation, preparation of agendas, and requiredscheduling coordination necessary for Review Committee meetings, as directed byIIR Program Managers.? Forwards appropriate IIR request data to Contracts & Outsourcing and reviewsinitial contracts created for correspondence with initial request, as directed by IIRProgram Managers.? Manages the transactional details of payment requests and documentation withFinance, GFSS or other appropriate Pfizer colleagues, as directed by IIR ProgramManagers and works with them to resolve payment processing issues.? Assists in the regular generation of requests to investigators for enrollment sweepsand study progress updates, and forwards documents received to IIR ProgramManagers.? Inputs IIR study milestones into the IIR system.? Uploads final documentation received from requestors and closes completedstudies in the IIR systems.? Assists IIR Program Managers with status report queries, as required.? Contributes to process and technology improvement projects within areas ofresponsibility, as requested.Training & Education Preferred? Bachelor’s degree.Prior Experience Requirement? Prior pharmaceutical experience preferred.? Familiarity with research or study management or monitoring preferred.CompetenciesTechnical Knowledge? Working knowledge of the principles and concepts of Investigator InitiatedResearch based on experience in Clinical Study or IIR study management, or arelated discipline.? General knowledge of drug product(s), disease characteristics, and research orstudy design.? Adept at the use of computer based tools and systems (e.g., tracking, financial,clinical supply, investigator credentialing, document management, etc.) used tosupport IIR study management.? Assumes responsibility, with supervision, for selected parts of study(ies) (e.g., drugsupply forecasting & ordering, patient enrollment, tracking).? Completes study-specific tasks and contributes to the delivery of milestones.? Identifies when issues are beyond own expertise and seeks input from appropriateteam members (e.g., more senior colleagues).? Performs assignments using established procedures and general instruction on theprocess and desired outcome.Decision Making? Makes decisions that require choosing between limited options to resolvemoderately complex problems.? Responds appropriately to routine questions raised by RMRSs, PCOs, and otherinternal stakeholders.? Correctly interprets and executes routine application of SOPs and processes.? Makes appropriate decisions related to maintaining a high level of data integrity andprocess compliance.Autonomy? Exercises judgment utilizing standard methods and techniques.? Assumes responsibility for, and organizes, a portion of a study’s milestones anddeliverables.? Identifies when issues are beyond own expertise and seeks input from appropriateteam members (e.g., more senior colleagues).? Respectfully challenges decisions or ideas to uphold integrity and ethical standards.? With limited support, reliably completes defined study responsibilities (e.g.,enrollment tracking, drug re-supply).? Contributes to process and technology improvement projects within area ofresponsibility.Teamwork / Collaboration? Develops effective and productive partnerships within the individual’s area ofresponsibility to aid in delivery of project goals.? Participates and contributes as an IIR study team member.? Shares best practices and strives for continuous improvement.? Takes responsibility for a portion of the IIR study team’s milestones anddeliverables (e.g., conducting enrollment sweeps).? Works with other team members proactively to identify moderately complexproblems on specific IIR study(ies) and helps determine solutions. 职能类别：生物工程/生物制药临床数据分析员

公司信息

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards. 辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。

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

武汉相关职位

职位描述

联系方式

公司信息