国内领先药厂
CRPM/SM-血液肿瘤
医疗医药
生物/制药/化工
上海, 北京
1-3年
硕士
面议
职位描述
1. Support medical director in drafting clinical trial protocol and study report.
2. Contribute to the medical/scientific input given for the development of trial-related documents such as IB, ICF etc. and processes which reside in other line functions.
3. Establish and maintain liaisons with investigators.
4. Prepare and conduct regular meetings with investigators.
5. Lead clinical trial data review and generate clinical queries, quality control and data validation for clinical study reports, publications and internal/external presentations.
6. Provide medical support to trial sites and clinical operation team as medical monitor.
7. Support clinical study site and CRO selection in trial conduct and clinical trial outsourcing process.
8. Support regulatory filing where medical expertise is required.
9. Support drug discovery when clinical experience is needed for the medical “translation”.
10. Support the regional clinical strategy for a project through Clinical development, in partnership with relevant matrix team members.
11. Compliance with GCP, SOP and regulatory requirements.
12. Study planning, preparation, conduct and report, in terms of timeline, quality and quantity (recruitment target).
13. Other tasks as assigned.
职位要求
1. Graduate from Clinical Medicine with master’s degree or above.
2. At least 3–5 years clinical practice / clinical development / clinical research experience. Therapeutic area experiences in hematology. Working experience in international pharmaceutical company or CRO is preferable. GCP experience is preferred.
3. Proficiency in English and good computer skill at office software.
4. Excellent planning, organization and problem-solving abilities.
5. Good communication and interpersonal skills.
6. Good project management skills.
7. Self-motivation and good risk management.
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