Clinical Research Expert

Job description

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 PositionJob 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. Master's 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 areA healthier future drives us to innovate. Together, more than 100’000 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. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.