Fortune 500
Clinical Research Expert - CD
医疗医药
医疗设备/医疗器械/医用耗材
上海, 北京
3-5年
硕士
¥20 - 35K/月
职位描述
1. Develop optimal clinical strategy and evaluation pathway for proposed registrable products, including timeline and
budget assessment.
负责制定拟注册产品最佳的临床策略和临床评价路径，并能完成时限和预算的评估。
2. Design feasible clinical trial timelines by integrating product characteristics with regulatory guidelines, clinical
practice standards, and expert consensus; independently author clinical trial protocols.
可根据拟注册产品的特点，并结合产品相关的注册指导原则、诊疗指南和专家共识等，制定合理的临床试
验时间计划，并能独立撰写临床试验方案。
3. Proactively identify and mitigate risks during trial execution to ensure successful study completion.
在临床试验开展过程中，能有效识别风险，并对风险进行合理的控制，确保临床试验能顺利完成。
4. Maintain close liaison with NMPA; coordinate communications with reviewers during regulatory evaluation until all
CR comments are adequately resolved.
与 NMPA 保持密切的沟通和联系，并在产品注册审评过程中负责与主审的沟通与协调，至所有的发补问题
均能得到有效解决。
5. When appointed as the clinical project lead, assumes responsibility for close collaboration with relevant colleagues
within the company and investigators, utilizing internal and external resources to ensure compliance with the overall
scientific objectives.
当被任命为临床项目负责人时，负责协调公司内部相关同事和研究者的活动，充分利用内、外部资源以确
保符合整体科学目标及项目的成功。
6. Build up effective communication methods to manage project members/teams and support and motivate others to
perform at their best
建立有效的沟通方法对项目成员/团队进行管理，支持、激励并鼓舞他人作出最佳表现。
7. May represent the company as primary contact on projects and conduct other projects or tasks assigned by line
manager.
可代表公司作为项目的主要联系人，并完成主管指派的其他任务。
8. If apply, develop and maintain a good working relationship with BAs and other dept. to support the cross-functional
projects
如适用, 开拓并维护与业务部门和其他部门的良好工作关系，以支持跨部门项目。
9. Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche
Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection
遵循罗氏所有合规要求，包括但不限于罗氏信息安全，罗氏商业中的行为，罗氏竞争法互动对话，罗氏安
全健康环境等，合法合理开展业务活动。
10. Understand and fulfill the responsibility of line manager's SHE tasks and duties (as defined in SHE handbook)
了解并执行直线经理的 SHE 职责（详见 SHE 手册相关定义）。
职位要求
Education& Qualifications 教育背景与专业资格:
1. At least Bachelor degree in medical science, preferably in clinical medicine, medical laboratory, biochemistry,
pharmacology, bio-engineering and biology
医学专业本科及以上学历,优先临床医学,医学检验,生物化学,药学,生物工程和生物学
2. Proficiency in English language skills
熟练掌握英文技能
3. Good command of MS office software application
熟练应用微软办公软件
4. Understand pharmaceutical and/or medical device regulation and ICH/GCP
了解体外诊断试剂及/或医疗器械法规和 ICH/GCP
Experience 工作经验:
1. At least 5 years of working experience in clinical research, clinical project management, data management in
clinical medicine, CRO, pharmaceutical, Medical Device, or in-vitro Diagnostics industries
临床医学，CRO，制药，医疗器械或体外诊断行业至少 5 年的临床研究，临床项目管理，或临床数据管理
相关工作经验
2. Effective oral and written communication skills; able to get ideas across face-to-face, in group settings as well as in
presentation
高效的口头及书面沟通技巧; 能够在面对面，小组演示中获得信息
3. Have the capacity to resolve complex problems through in-depth evaluation of various factors
具备通过对各种因素的深入评估来解决复杂问题
4. Have the capacity to resolve conflicts constructively from the perspective of all stakeholders
能够站在各个利益相关者的角度，建设性地化解矛盾
5. Have the capacity to identify and gain support from others to achieve recognition and solutions
能够识别和获得他人的支持，并达成共识获得解决方案
6. Have the capacity to communicate and coordinate with multi-functional team
具备多职能团队的沟通和协调能力
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