上海 [切换城市] 上海招聘上海生物/制药/医疗器械招聘上海生物工程/生物制药招聘

Investigator Initiated Research Associate

辉瑞(中国)研究开发有限公司

  • 公司规模:10000人以上
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2014-04-21
  • 工作地点:武汉
  • 招聘人数:1
  • 职位类别:生物工程/生物制药  

职位描述

Position Purpose
? The Investigator Initiated Research (IIR) Associate provides primary support to IIR Program Managers with necessary communication and coordination to ensure efficient processing of Investigator Initiated Research (IIR) requests.
? The IIR Associate is responsible for ensuring study progress including document management and distribution, ensuring entry of IIR proposals into the system, monitoring proposal status for IIR Program Managers, and securing and entering study 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 completeness and/or enters requests into IIR systems, including uploading and scanning.
? Entry of information into the IIR system, acknowledgment communications, and requests for additional information or documentation through the entire lifecycle of assigned IIR studies.
? Assists PCO colleagues who are completing the IIR submissions in INSPIIRE to address missing information and ensures compliance to Pfizer’s policies on Safety Reporting, FCPA, HCP and Privacy.
? Manages distribution of documentation, preparation of agendas, and assists with scheduling coordination necessary for Review Committee meetings for IIR programs.
? Manages the transactional details of drug supply requests (i.e. generating drug supply forms) and works with IIR Program Managers and Pharmaceutical Sciences Supply Chain Coordinators to ensure clinical supply forecasts are up-to-date and supplies are available as required for IIR studies.
? Contacts requestors for missing or requested documentation, as directed by IIR Program Managers.
? Prepares required correspondence to IIR requestors and Pfizer colleagues, including acknowledgement letters to requestors and communications to Review Committee members, RMRS, Regional, or PCO colleagues. Works with IIR Program Managers to issue correspondence.
? Manages distribution of documentation, preparation of agendas, and required scheduling coordination necessary for Review Committee meetings, as directed by IIR Program Managers.
? Forwards appropriate IIR request data to Contracts & Outsourcing and reviews initial contracts created for correspondence with initial request, as directed by IIR Program Managers.
? Manages the transactional details of payment requests and documentation with Finance, NASS or other appropriate Pfizer colleagues, as directed by IIR Program Managers and works with them to resolve payment processing issues.
? Assists in the regular generation of requests to investigators for enrollment sweeps and study progress updates, and forwards documents received to IIR Program Managers.
? Inputs IIR study milestones into the IIR system.
? Uploads final documentation received from requestors and closes completed studies in the IIR systems.
? Assists IIR Program Managers with status report queries, as required.
? Contributes to process and technology improvement projects within areas of responsibility, as requested.

Training & Education Preferred
? Bachelor’s degree.

Prior Experience Requirement
? Prior pharmaceutical experience preferred.
? Familiarity with research or study management or monitoring preferred.

Competencies
Technical Knowledge
? Working knowledge of the principles and concepts of Investigator Initiated Research based on experience in Clinical Study or IIR study management, or a related discipline.
? General knowledge of drug product(s), disease characteristics, and research or study design.
? Adept at the use of computer based tools and systems (e.g., tracking, financial, clinical supply, investigator credentialing, document management, etc.) used to support IIR study management.
? Assumes responsibility, with supervision, for selected parts of study(ies) (e.g., drug supply 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 appropriate team members (e.g., more senior colleagues).
? Performs assignments using established procedures and general instruction on the process and desired outcome.

Decision Making
? Makes decisions that require choosing between limited options to resolve moderately complex problems.
? Responds appropriately to routine questions raised by RMRSs, PCOs, and other internal stakeholders.
? Correctly interprets and executes routine application of SOPs and processes.
? Makes appropriate decisions related to maintaining a high level of data integrity and process compliance.

Autonomy
? Exercises judgment utilizing standard methods and techniques.
? Assumes responsibility for, and organizes, a portion of a study’s milestones and deliverables.
? Identifies when issues are beyond own expertise and seeks input from appropriate team 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 of responsibility.

Teamwork / Collaboration
? Develops effective and productive partnerships within the individual’s area of responsibility 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 and deliverables (e.g., conducting enrollment sweeps).
? Works with other team members proactively to identify moderately complex problems on specific IIR study(ies) and helps determine solutions.

公司介绍

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。

联系方式

  • Email:ChinaCPWTalent@Pfizer.com
  • 公司地址:1 (邮编:200000)