研究者发起试验项目管理专员招聘_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：岗位介绍： The IRC Associate provides primary operational support to various programs within Medical Affairs Platform Strategy (MAPS) group which including but not limited to Investigator Initiated Research (IIR), Clinical Research and Collaboration (CRC), Compound Transfer Program (CTP), Clinical Data Request (CTD), Independent Grants for Learning & Change (IGLC) and Publications Programs. The major responsibilities including but not limited to: Maintaining systems, Share Point sites and databases used for program management; Receive, generate and distribute program related documents & report according corresponding Pfizer SOPs and guidelines; Process eligibility check, finance transactions and drug distribution as requested. The IRC Associate will work closely with program managers with necessary communication and coordination to ensure efficient program process and compliance. 岗位职责: The support area of Non-Pfizer sponsored research grants including but not limited to: ? Reviews incoming Non-Pfizer sponsored research requests and documents for accuracy and completeness; enters requests into research management system and prepares required correspondence to external requestors & Pfizer colleagues, such communications to investigator, Review Committee members, Field Based Medical, Regional, or PCO colleagues. ? Manages distribution of study related documentation, preparation of meeting agendas, and assists with scheduling review meetings or due diligence review for Non-Pfizer sponsored research programs; contacts requestors for missing or requested documentation, as directed by CRC Liaisons and /or IIR Program Managers. ? Manages financial transactional details as well as drug supply requests (i.e. generating drug supply forms) based upon executed contract and study milestones; works with IIR Program Managers / CRC Liaisons and Pharmaceutical Sciences Supply Chain Coordinators to ensure clinical supply forecasts are up-to-date and supplies are available as required. ? Assists regular study oversight activities such as generation of requests to investigators for enrollment sweeps and study progress updates, forwards documents to appropriate reviewer and keep the research management system updated. ? Maintain expertise of Non-Pfizer sponsored research process and policy, assists PCO colleagues who are completing the submissions in research management system to address missing information and ensures compliance to Pfizer’s policies on Safety Reporting, FCPA, HCP and Privacy (as required). ? Uploads final deliverables received from requestors and closes completed studies in the research management systems. ? Assists CRC Liaisons or IIR Program Managers with status report, queries and other logistic support as required. ? Contributes to process and technology improvement projects within areas of responsibility, as requested. The support areas of IGLC program including not limited to: ? Perform compliance check of organizations against internal and external watch lists (such as OIG); check promotional speakers (EZspeak, iMAS); review potential external review panel nominees against multiple database (e.g., EZspeak, CAL); verify requestor accreditations (e.g., ensure accredited org is ‘requesting org’ for grant request; obtain supporting documentation when accreditation is activity-based). ? Obtain IRB approval/exemption documentation for Quality Improvement grants (when applicable); check PI against multiple databases D&I Research (e.g., CAL, INSPIIRE for CRC, and other external references). ? Asist financial payments for all IGLC programs, identifies existing, valid vendor IDs or creates them when necessary in Ariba/SAP. Ensure current W8/W9 form obtained and completed appropriately. Resolves payment process issues, initiates reissuance for lost checks, resolves technical issues (SAP, GMS), and follows up with GFSS as necessary. ? Maintain and track grant management system access for both internal and external individuals. For Pfizer internal individuals, ensure required training is appropriately assigned in P2L. For external individuals (such as ERP member, RFP partnerships), obtain user access agreement as needed. ? Periodically pull program related information form grant management system and posted on Pfizer home page and internal Share Point site using populated templets and formats to meet stakeholder needs. ? Participates in any grant monitoring activities (e.g., follow-up on milestone data, outcomes data). Refreshes reports; distributes to specific DLs and/or posts to IGLC SharePoint/intranet per set schedule. ? Promotes consistency and standards with internal processes and deliverables; performs QC reviews according to relevant SOPs and job aides; assists in training others and maintaining training documents; assists in metrics compilation and raises potential compliance risks. ? Assists ILGC manager in ensuring the compliance of all IGLC systems and processes with internal and external compliance requirements, policies, and guidelines; provides support during audits. ? Coordinates with Pfizer country offices and regional colleagues to provide operational support as required to execute IGLC global strategic initiatives. The support area of publication including but not limited to: ? Support publication activities by completing watch list checks and related forms, in relation to determining if external manuscript authors are included on any debarment watch lists, as per publication SOP ? Responsible for providing access to DataVision (DV) to internal and external stakeholders by ensuring that appropriate training has been completed for the requested role ? In partnership with the Publication Specialists and Publication Manager of Operations, support the management of monthly invoice processing from publication vendors (~200 invoices/month), including reconciliation of records in DataVision (DV) and confirmation of receipt of deliverables prior to invoice payments. The support area of INSPIIRE system admin & helpdesk service including but not limited to: ? Serve as INSPIIRE systems administer to manage user access, project team assignment and general oversight INSPIIRE systems (INSPIIRE external Portal website and internal workflow/database management system), resolve simply to moderate complex system issues. ? Handles helpdesk requests from external and internal stakeholders, develop FAQ and guidance material to improve user experience and satisfaction. ? Develops and delivers training materials regarding system functionality, internal workflow and document management, provides INSPIIRE customer database stewardship in cooperation with the INSPIIRE system support team. ? Periodically pulls data from the INSPIIRE system to provide continuous monitoring of IIR/CTP/CRC program, apply advance data analysis and reporting tools to identify non-compliance and CAPA action items, for example, data accuracy, completeness and/or discrepant (with source data) information and/or documentations in the system according applicable Pfizer policies, SOPs and local WIs/Guidelines. ? Maintain the helpdesk mailbox, creates and distribute standardized or ad hoc report as scheduled or based upon request. Summarize action items of business reports and communicates with responsible grants management team appropriately, follow up with finding resolutions and corrective actions. Records findings and follow up correspondences in centralized area for tracking and reporting purposes. ? Works with the INSPIIRE support team as an SME for testing and developing improvements to the program management portal / system. Contributes to process and business technology improvement projects within areas of responsibility, as requested. 岗位要求： Bachelor’s degree (BA, BS) required with preference for a focus in science, healthcare or related field. Good written and oral English skills, Japanese fluency highly desired. Operational experience in clinical trial management, educational grants or healthcare industry (pharmaceuticals, life sciences, and medical). Knowledge of IT systems/software for database maintenance and document management. Demonstrated effectiveness working in a multidisciplinary, matrix team situation, and demonstrated ability to manage change and diversity. Good understanding of multiple disciplines (e.g., Healthcare Compliance Law, Regulatory, Drug Supply, Clinical Study, Medical Affairs, Medical Educational Grant, Publication development, Project and Financial Management) and organizations (e.g., Pfizer Country Offices and Regions) Experience with various Pfizer processes/systems/functions: MAPP (FCPA), Ariba SAP reporting strongly preferred. Developed customer service skills and team work spirit. 职能类别：临床研究员临床数据分析员

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

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