Clinical project manager
description of job
1. Responsible for the project management of the company's clinical trials, conduct comprehensive quality control and progress management of the clinical research projects (BE trials) in charge, and ensure all trials; the inspections strictly follow the clinical trial plan, standard operating procedures / internal operating procedures And Chinese regulations;
2. As the main contact person of the clinical trial, on behalf of the company and the project team, communicate with the researchers and the CRO in a timely and effective manner to ensure that the important information related to the project is accurately and completely transmitted, and cultivate and maintain a good relationship with the center and the CRO;
3. Perform comprehensive quality control and management of the clinical research projects in charge, supervise the completion, start and execution of clinical trials at home and abroad, and communicate and coordinate with relevant personnel in a timely manner, such as finance, administration, registration , QA personnel, etc .;
4. Develop a project management plan, determine the scope of responsibility for clinical research, team members, schedules and other content, and continuously review and modify the project management plan during the project to ensure that the clinical research meets the needs of the timeline;
5. Responsible for communicating with CRO and superior leaders in a timely manner, identifying, monitoring and timely responding to various risks during the project, and correctly assessing the overall impact of the corresponding risks on the project;
6. Responsible for reviewing all routine ongoing quality control and progress reports;
7. Writing of some registration materials. Researcher's manual, preclinical and clinical review, etc .;
8. Literature support for experimental scheme design.
9. Coordinate drug mailing and transportation;
10. For projects in need, can assume the role of CRA and work.
1.2 years of project management experience, more than 5 project operation experience; including BE test operation experience, overseas communication experience is preferred.
2. Bachelor degree or above in pharmacy or clinical medicine.
3． English can be used as a working language. Good communication skills are available in Cantonese.
Since its establishment in Hong Kong in 1993, Ao Mei Pharmaceutical is a modern multi-national pharmaceutical company with multi-functional production plants and nearly 5,000 employees in Hong Kong. It has developed into a pharmaceutical group enterprise integrating production, supply, research and development, and sales. , Is a GMP teaching demonstration base for many universities in Hong Kong, and is a local production base designated by the Hong Kong Hospital Authority to supply hospital medicines in Hong Kong. The Group has established R & D centers in Hong Kong and Haikou, and plans to establish new R & D centers in Suzhou and the United States.
Australian American Pharmaceutical (Suzhou) Co., Ltd. is located in Suzhou High-tech Zone (Huqiu District), with a registered capital of 26.25 million US dollars and a planned total investment of 60 million US dollars. It is planned to build a comprehensive pharmaceutical company that includes pharmaceutical production, import subcontracting, and research and development centers. .
Relying on the “Yangtze River Delta” biomedicine circle, the Australian-American Pharmaceutical (Suzhou) R & D Center will use regional talents, resources and policy advantages to focus on biotechnology development and innovation, build new drug and plant drug R & D platforms, and establish drug preparation, analysis and testing centers. It echoes with Haikou and overseas R & D bases to form a complete drug research and development system from health products, botanical drugs, generic drugs to the creation of new drugs.
Based on the quality management concept of "Quality by Design" and the quality management tenet of "Quality First, Customer First", the company has established a set of its own QbD R & D process and R & D project management mode. Strict quality assurance system, from the quality control of pharmaceutical research and development, quality management of raw and auxiliary materials, quality control throughout the production process, product quality inspection, quality risk assessment to product after-sales quality monitoring, in line with EU PICs GMP high quality management system.
Job posting company
Australian American Pharmaceutical (Suzhou) Co., Ltd.
Enterprise Nature: Foreign-funded Enterprise
Enterprise size: 50-99 people
Year of establishment: 2013
Enterprise website: http://www.brightfuturehn.com.cn/sc
Business address: No. 186, Xinzhen Road, Tong'an Town , Suzhou High-tech Zone
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