1. Job Purpose
Lead the medical oversight of the clinical studies and ensure subject safety, site medical compliance with protocol and ICH-GCP requirements, and overall scientific integrity and quality of the clinical studies.
2. Responsibilities
(a) Proactively provide the medical leadership to improve the project quality.
(b) Provide scientific and medical input in the clinical study.
(c) Develop the medical monitoring plan for the project.
(d) Provide the medical training to the relative study team members.
(e) Provide the medical input with regard to the clinical safety concern.
(f) Involve in the project team meetings with medical consultation if necessary.
(g) Involve in the internal training courses related to medical monitoring.
3. Qualifications
(a) Academic / Major
(b) Professional Skills
- Familiar with the knowledge of the clinical practice in one therapeutic area at least （Oncology preferred）, GCP and the SOP of clinical study.
(c) Working Experience
- At least 2-year experience of clinical practice in the hospital (the experience of medical affairs in the pharmaceuticals factory is preferred).
- The excellent candidates will not be restricted to the current requirements.
(d) Language ability
- Fluent in written and verbal English.
(e) Computer Literacy
- Good skills on Microsoft Word, Excel, PPT and Outlook, etc.
(f) Other abilities such as Communication skills/Information-gathering skills.
Good communication skill, time management skill and project management skill.
