长沙招聘

ROLE SUMMARY
Real World Evidence (RWE) generation is a critical strategy for Medical Affairs enterprise wide. Medical Affairs led HEOR Non-Interventional Study (NIS) and Low Interventional Study (LIS) RWD collection, evidence generation and outcomes & analytics are key to deliver BU medical evidence generation strategies. The Medical Evidence Generation Study Assistant is part of the team for RWE studies, and is responsible for supporting the Project Manager (PM) for assigned studies to ensure compliance with ICH-GCP, SOPs, and regulatory regulations. The role collaborates directly with PM and as required with other team members and supports them in the efficient execution of clinical studies.
ROLE RESPONSIBILITIES
Provides study level operational support to the Core Study Team from study start up to close out and submission with general direction:
Management of Study Team shared spaces
Trial Master File (TMF) maintenance and compliance
Data entry on Study Management Platform: Support and follow up on metrics under the surveillance of PM
Study Management system(s) compliance and maintenance
Tracking of study level information; follow up with functional lines as needed
Liaising with cross functional study team members: Execute the completion of study level forms and data entry into various clinical operations applications and systems
Quality Control (QC) of essential clinical study documents
Provides logistical/operational support to Study Management for Investigator Meetings
Provides status updates on key tasks and activities to the Project Manager and contribute to the Core Study Team Meetings
Works proactively to prioritize multiple study tasks in support of clinical study systems and processes
Uses established procedures and methodologies to ensure the completion of assigned tasks according to timelines and to required quality standards
Supports short term Operational Special Project requests (e.g. workstreams, initiatives, projects)
Manages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables)
QUALIFICATIONS
Basic Requirement
(B.S or B.A) with 0 to 2 years’ experience
Preferred Requirements
Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research
Science background
Effective verbal and written English communication skills
Ability to work independently but also as part of a larger team
Ability to multitask and manage multiple competing priorities
Self-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high quality
Basic Knowledge of drug development process
Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.
Good problem solving & decision-making skills: Ability to work in ambiguous situations within the team Seek input from others when faced with a difficult situation; Make sound decisions within the scope of responsibility; Focus on resolving problem
Technical Competencies
Administrative and technical capabilities are required.
Knowledge of IT systems/software for database maintenance and document management.
Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel, TEAMS)
Demonstrated effectiveness working in a multidisciplinary, matrix team situation, and demonstrated ability to manage change and diversity.

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。