Working at I-Mab

As a young biotech company, I-Mab has been expanding rapidly and providing ample opportunities of career advancement for our employees. We believe that the team spirit and passion for innovation and perfection are critical for our continued success and our enduring corporate values. I-Mab is committed to creating a career development platform for our employees to explore their potential and fulfill their dreams.

Join us

We are passionate about bringing transformational therapies to patients around the world. If you share our passion, you are warmly welcomed to join the I-Mab family and our journey in making a positive impact on patients’ lives.

For consideration of any open positions, please send your resume to:

hrdept@i-mabbiopharma.com
CRA
Shanghai, China
Department of clinical operation, R&D

Job description:

Position summary


Be able to carry out the clinical supervision of the program and research center independently. To ensure that clinical studies are carried out in accordance with test protocols, standard operating procedures (SOP), drug clinical trial quality management (GCP) and ich-gcp and applicable laws and regulations.Duties and responsibilities


· screening, starting, monitoring and closing of visits to the research center according to the test plan, the scope of work specified in the contract, the requirements of SOP and GCP.

· can be responsible for the supervision of research centers in multiple programmes, research centers and therapeutic areas at the same time.

· carry out programme and research related training for the research center in charge and conduct regular communication with the research center to manage the requirements and problems in the project.

· evaluate the quality of the work of the research center, the completeness and authenticity of the data, and determine whether the research center is conducted according to the plan and applicable regulations. Report quality issues to responsible PM and/or line manager.

· management is responsible for the progress of the research center, through the screening of the central case, the completion of the group, the case report (CRF), and the data query generation and resolution.· create and maintain documents related to the management of the research center, monitor visits and action plans, and submit the visit report and other required research documents.

· responsible for the financial management of the corresponding research center.

· work with other functional departments.

· complete other tasks assigned by line manager and/or project manager (PM).Knowledge, skills and abilities required.

· good knowledge of clinical research and understanding of applicable regulatory requirements.· master the knowledge of the program requirements through the company training.

· good computer skills, including proficiency in Microsoft Word, Excel and PowerPoint.

· good verbal and written communication skills.

· good organization and problem-solving skills.

· effective time management skills that can handle conflict work at the same time.

· ability to establish and maintain efficient working relationships with researchers, colleagues, line managers and customers.

· always comply with SOP requirements.

· can think independently and improve process.Minimum education and experience requirements.

· bachelor degree in clinical medicine, pharmacology, nursing, health management or other related disciplines.

· 1 year clinical research or clinical supervision experience.

· at least cet-4.

Send your resume
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