Clinical Research Expert

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

Job Summary职位概述:

1. Independently plan and execute clinical development activities for new clinical software instrument platforms IVD assays medical devices etc. developed globally by the Roche Diagnostics ultimately supporting product registration in China. Manage all phases of clinical clinical development in strict compliance with company SOPs policies divisional standards the Declaration of Helsinki relevant GxPs NMPA regulations and other international requirements or industry best practices.

独立规划并执行临床开发活动为罗氏诊断在全球开发的新型临床软件仪器平台体外诊断试剂医疗器械等产品在中国的注册提供支持严格遵守公司SOP政策部门标准赫尔辛基宣言相关GxP规范NMPA法规及其他国际要求与行业最佳实践

2. Conduct comprehensive information gathering and evaluation for proposed registrational products to formulate optimal clinical strategies and clinical evaluation pathways. Furthermore accurately assess and determine clinical trial timelines and budgets based on the defined pathways.

对拟注册产品进行全面的信息收集与评估制定当前最优的临床策略与临床评价路径同时能够基于既定的评价路径准确完成临床试验时限与预算的评估

3. Be familiar with product characteristics regulatory guidelines and expert consensus within relevant therapeutic or diagnostic fields. Independently design scientifically rigorous clinical trial protocols.

熟悉拟注册产品的特点及相关领域的指导原则与专家共识能够独立设计科学严谨的临床研究方案

4. Leverage expertise in relevant disease areas and product performance metrics to independently author scientifically rigorous clinical study reports (CSRs) and academic publications.

运用对疾病领域及产品性能指标的专业知识能独立撰写科学严谨的临床研究报告及学术文献

5. Maintain profound knowledge of regulatory requirements continuously monitor regulatory trends and timely assess their impact on ongoing projects.

熟悉各项法规要求密切关注法规动态并能及时分析与判断其对项目产生的影响

6. Demonstrate an understanding of company and departmental policies SOPs and cross-functional business linkages. Drive continuous innovation and propose agile solutions to optimize operations.

理解公司及部门的各项政策规章制度SOP以及跨部门的业务协同关系具备推动创新的能力能够提出更为敏捷高效的业务建议

7. Proactively identify evaluate and mitigate emerging risks within a dynamic and changing environment to ensure smooth trial execution and operational continuity.

在动态变化的环境中能够敏锐有效地识别潜在的新风险并实施合理的风险控制措施

Main Tasks & Responsibilities主要工作职责 :

1. Develop optimal clinical strategies and clinical pathways for proposed registrational products including comprehensive timeline and budget assessments.

负责制定拟注册产品的最佳临床策略和临床路径并完成全面的时限与预算评估

2. Design feasible clinical trial timelines by integrating product characteristics with regulatory guidelines clinical practice standards and expert consensus; independently author clinical trial protocols.

结合产品特点相关注册指导原则诊疗指南及专家共识制定合理的临床试验时间计划独立撰写临床试验方案

3. Proactively identify and mitigate risks during clinical study execution to ensure smooth and successful study completion.

主动识别临床研究执行过程中的风险并进行合理控制确保临床研究顺利完成

4. Independently author logically rigorous clinical study reports (CSRs) and high-quality scientific publications.

独立撰写逻辑严谨的临床研究报告及高质量学术文献

5. Maintain close liaison with the NMPA; coordinate and lead communications with reviewers during the regulatory evaluation process until all clinical deficiencies/queries are adequately resolved.

与 NMPA 保持密切沟通负责产品注册审评期间与审评员的沟通与协调直至所有临床发补问题得到有效解决

6. Coordinate internal cross-functional teams and external investigators (as applicable) during clinical development optimizing both internal and external resources to meet overall scientific objectives and drive project success.

统筹协调临床开发过程中的内部跨功能团队与外部研究者如适用高效整合内外资源确保项目符合整体科学目标并取得成功

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 with all corporate policies and legal requirements including but not limited to Roche Secure Roche Behavior in Business Roche Competition Law Interactive Dialogues and Roche Safety Security Health and Environmental Protection (SHE).

严格遵循罗氏的所有合规要求合法合理地开展业务活动包括但不限于罗氏信息安全罗氏商业行为准则罗氏竞争法互动对话罗氏安全健康与环境保护SHE等

10. Understand and fulfill the SHE tasks and duties required of a line manager (as defined in the SHE handbook).

了解并执行直线经理的SHE职责详见SHE手册相关定义

Basic Requirements of the Job基本任职资格:

Education & Qualifications教育背景与专业资格:
1. Masters degree or above in Medical Sciences Life Sciences or a related field. Majors in Clinical Medicine Medical Laboratory Science Preventive Medicine Pharmacy or related fields are highly preferred.
医学生命科学或相关专业硕士及以上学历;优先考虑临床医学医学检验预防医学药学等相关专业
2. Proficiency in English language skills
熟练掌握英文技能
3. Good command of MS/Google office software application
熟练应用微软/谷歌办公软件
4. Understand medical device (including IVD) regulations and medical device GCP.
了解医疗器械(含体外诊断试剂)法规和医疗器械 GCP

Experience工作经验:
1. Minimum of 7 years experience in clinical research or clinical development within the pharmaceutical medical device in-vitro diagnostics (IVD) or CRO industries.
具备至少7年制药医疗器械体外诊断试剂或 CRO行业的临床研究临床开发相关工作经验
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

Travel Requirements 出差要求:
1. Approximately 20% of time local and/or international travel.
大约20%的时间是本地和/或国际出差

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.