Clinical Trial Management Assistant (Internship/Full-time)
Host Company Profile
The host was established in 1996 and is a pharmaceutical company engaged in research, manufacturing and sales of medicine, matching the GMP standard in its design and construction. Covering an area of 133,333 square meters, he company is located in the fertile and vast Chengdu Plain which is crowned as a natural treasure. With a modern managerial system and with the efforts of its employees over the past 7 years, the company now has assets of 220 million yuan ($35.46 million) and an annual production capacity of 500 million yuan. The annual output is worth 150 million yuan . In April 2001, the company obtained a Technological Enterprise Certificate granted by the Scientific and Technological Committee of Sichuan Province. In March, 2002, the company was named as one of the promising technological enterprises of Chengdu . In October 1998, the Sichuan Drug Administration reviewed the company’s Quality Control Department based on the GMP standard. The result showed that it had reached B-standard set by the quality inspection agency of pharmaceutical companies.
Assist in the R&D department in on-going projects
Lead the efforts for analytical development studies within ARD department; function as project leader role in analytical development projects
Plan and execute analytical method development and validation for drug substances/drug products; perform sample analyses including but not limited to samples for drug substances /drug products used for clinical trials
Plan, Coordinate, and oversee the work activities of scientific staff within the assigned group
Be responsible for project management starting from project execution/project following up, regular analytical development update, review and approval of analytical protocols/reports. Assist the interaction with partners by issuing project reports, entertaining on-site visitation and through tele-, web- or video-conferencing etc
Be responsible for improving the operation efficiency and productivity while ensuring the current quality systems in full compliance to all applicable regulatory standards
Perform daily management of the analytical labs; conduct the group training in technology and compliance as needed
Bachelor degree or above, clinical, pharmaceutical and other related majors.
Familiar with the professional knowledge of the standardized management of clinical trials
Familiar with the drug registration management methods
Familiar with the whole process of drug research and development and related guiding principles
Familiar with the new drug clinical trial procedures and technical guidelines
Familiar with basic knowledge of official document writing
Good English listening, speaking, reading and writing skills
Great opportunity of working in China and gaining international working experience
Monthly Cultural and social networking activities
Full-time job opportunities
To apply for the program please read more details on our Internship in China page and apply via there.