Clinical Medical Assistant Manager（2022应届生）

Main Responsibilities:
1.Assist Clinical Medical Manager (including Senior Manager, AssociateManager or other) in writing clinical trial protocol, clinical studyreport and related materials in clinical study(e.g. the clinical part ofIND and NDA, or ethical materials);协助医学经理（包括副经理、高级经理等）撰写临床方案、临床研究总结报告及临床试验相关材料（包括IND 或NDA 中临床材料、伦理材料）；
2. Make brief documents review about developing products; 负责研发产品相关文献简述；
3. Assist Clinical Medical Manager (including Senior Manager, AssociateManager or other) in reviewing clinical trial documents, such as CaseReport Form (CRF), Statistical Analysis Plan (SAP), Data Management Plan(DMP) and Drug Safety Report Management Plan and so on. Make sure thesedocuments are completed before the deadline; 协助医学经理（包括副经理、高级经理等）审核临床试验相关文件，包括但不限于：CRF、数据统计分析计划、数据管理计划，药物安全报告管理计划等，确保在临床试验的相关节点前完成；
4. Assist Clinical Medical Manager (including Senior Manager, AssociateManager or other) in reviewing medical information, finding and solvingrelated medical problems timely during clinical trials; 在临床试验阶段，协助医学经理（包括副经理、高级经理等）完成医学审核，及时发现研究中存在的问题并予以解决；
5. Assist Clinical Medical Manager (including Senior Manager, AssociateManager or other) in making clinical development plan and completingclinical trial protocol design under the leadership of developingdirectors; 在开发总监带领下（如有），协助医学经理（包括副经理、高级经理等）制定临床研发计划、完成临床研究设计；
6. Assist Clinical Medical Manager (including Senior Manager, AssociateManager or other) in solving medical problems and analyze data relatedto medicine in clinical study. Make sure the clinical study conform toclinical trial protocol, ICH, GCP and company SOP.协助医学经理（包括副经理、高级经理等）解决临床试验中医学相关的问题以及分析相关数据，确保临床研究严格按照研究方案和ICH-GCP, 国家相关法规、公司SOP进行。


Job Description:
1. Support the Head of Clinical Biostatistics to establish the team witha culture of excellence and high performance;协助医学经理（包括副经理、高级经理等）完成上市前临床研究的设计；
2. Assist Clinical Medical Manager (including Senior Manager, AssociateManager or other) with the pre-IND study design;协助医学经理（包括副经理、高级经理等）临床研究中所需医学资料的撰写；
3. Assist Clinical Medical Manager (including Senior Manager, AssociateManager or other) in writing medical materials required in clinicalstudy; 协助医学经理（包括副经理、高级经理等）解决临床试验中医学相关的问题以及分析相关数据；
4. Assist Clinical Medical Manager (including Senior Manager, AssociateManager or other) in solving medical problems and analyzing related datain clinical study; 协助医学经理（包括副经理、高级经理等）与临床专家及国家药品审评部门保持专业的沟通。


Qualifications: (Training, Education & Prior Experience):
1. Education required: Specialized master degree of clinical medicine orabove. 学历要求：临床医学专业硕士及以上学历。
2. Work experience: Fresh graduates without work experience. 工作经验：可以为应届毕业生。


Ability Requirements 能力要求：
1) 具有清晰地书面和口头表达能力，善于沟通；
2) 具有较强的执行力；
3) 具有较强的集体意识和良好的团队合作精神；
4) 具有良好的问题解决能力及应急预案管理能力；
5) 时间观念强，能合理计划时间并在计划的时限内按时完成工作
6) 具有良好的适应能力，可以承受合理的任务压力；
7) 注重工作细节，对工作有耐心。

加分项：具有医师资格证

Tips: 该岗位是2022届应届生招聘职位。工作地可选择驻地上海、连云港或南京。