Clinical Medicine
Medical Manager
Posted:
You will connect the medical work across clinical experts, study protocols, data analysis and regulatory documents. As studies progress, you will assess safety information, resolve medical issues and build relationships with principal investigators. The role combines clinical judgment with project coordination and clear medical writing in Chinese and English.
Your work
- Lead medical coordination for clinical projects, including expert discussions, protocol discussions and revisions, data analysis, study summaries and publications.
- Review and revise protocols, investigator brochures, case report forms and other study materials, along with clinical study reports, clinical overviews and related submission documents.
- Medically assess adverse reactions during clinical research and ensure that the work meets GCP and protocol requirements.
- Organize routine and ad hoc study audits with medical colleagues, identifying and resolving medical issues promptly.
- Work with regulatory colleagues to draft the medical documents needed for registration, and stay current with developments in the relevant disease areas.
- Build and maintain a principal-investigator network and the company’s expert database.
What you bring
- A master’s degree or doctorate in clinical medicine.
- At least three years of experience in a pharmaceutical company or clinical CRO, with a research background in endocrinology.
- Experience with phase I, II and III projects, plus clinical-trial monitoring and management experience across at least five studies.
- Knowledge of ICH-GCP and China GCP requirements.
- Strong communication and project management skills, with the ability to write clear, well-prepared materials in Chinese and English.
- Good organizational, planning and interpersonal skills.
Preferred experience
- Experience with diabetes projects.
Original posting · Chinese
医学经理
岗位职责
1、主导临床研究项目的医学对接与协作，包括（但不限于）：专家沟通、方案讨论修订、数据分析总结发表等工作，负责临床研究项目临床方案、研究者手册、病例报告表等相关资料的审核及修订，临床总结报告、临床研究综述等临床部分申报资料的审核及修订工作； 2、负责对临床研究过程中出现的各类不良反应进行医学分析，确保符合 GCP 以及临床方案的要求； 3、组织医学部相关人员定期或不定期地对临床研究进行稽查，及时发现并解决在临床试验中发生的医学相关问题； 4、配合注册部门起草注册所需的相关医学文件，跟踪相关疾病领域的医学信息； 5、建设和维护主要研究者网络，建立公司专家库； 6、其他：完成上级交办或授权处理的其他事项。
任职要求
1、临床医学专业，硕士或者博士以上学历（有糖尿病项目经验者优先）； 2、3年以上制药企业或临床CRO公司经验，有内分泌领域相关研究工作背景； 3、有过Ⅰ、Ⅱ、Ⅲ期项目经验； 4、熟悉 ICH-GCP 和中国 GCP，5个以上临床试验项目监查、管理经验。 5、出色的沟通表达能力与项目管理能力，具备较好的文案（中英文）写作能力； 6、良好的组织及计划能力，良好的人际交往能力。