工作地点：

香港特别行政区

工作职责：

主要职责定位Major Duties and Responsibilities Summary
主导国际临床试验涉及的流行病学的调研、临床试验方案的撰写、临床试验伦理、注册申报和对机构问题的答复等，支持产品在境外的上市注册。
Lead epidemiology research, clinical trial protocol writing, clinical trial ethics/regulatory submissions, and responses to institutional inquiries for international clinical trials, supporting the overseas marketing authorization of products.

主要职责Major Duties and Responsibilities

1、（项目开发）调研流行病学信息和相关产品的临床开发策略，主导或参与制定国际临床试验的开发计划和注册目标。
2、（方案撰写）研究和调查疾病和药物的作用原理，制定高水平的国际临床试验方案，包括试验方案设计、理论基础、入选标准、干预措施等。
3、（临床申请）依据相应国家伦理委员会的要求准备临床试验用材料，对伦理、药监等机构提出的问题进行书面或线上解答；协同PM和注册部进行Pre-IND材料的准备和后期问题的回复。
4、（项目管理）进行国际临床试验项目的日常管理，包括项目进度的追踪、问题的记录和汇报、以及所需资源的协调和管理，确保项目的顺利进行。
5、（现场管理）管理和协调临床现场，包括但不限于参与者招募、数据监查、试验物流等，能够流利使用英文进行沟通和交流，保障临床现场流程顺利推进。
6、（结果审核）科学地审核、分析和解读临床试验结果，按需编写或整合临床数据和报告。
7、（注册支持）协助产品的国际上市注册，包括参与制定注册策略、编写注册申请文件，与相关国家和地区的药品管理机构沟通，并能有效应对注册过程中的问题，支持产品的注册。
8、（前沿追踪）洞悉临床试验领域的创新性、前瞻性技术和方法，并且结合现有项目情况，提出创新的试验设计和执行方案，推动临床试验效率和质量的提升。
9、（流程制定与优化）制定和优化国际临床项目管理相关的SOPs，主导国际临床项目管理流程的优化和改进策略，通过引入新的方式方法改善现有流程，提升相关工作的质量和效率。
10、（协同合作）解决国际临床项目管理过程中遇到的复杂问题，提供相关技术支持和指导，与团队成员和其他部门紧密合作，确保上下游衔接顺畅。

1.(Project Development) Conduct epidemiological research and analyze clinical development strategies for related products. Lead or participate in formulating clinical development plans and registration objectives for international clinical trials.
2.(Protocol Writing) Study and investigate the mechanisms of diseases and drugs, and develop high-quality international clinical trial protocols, including trial design, rationale, inclusion criteria, intervention, etc.
3. (Clinical Applications) Prepare clinical trial materials in accordance with the requirements of respective national ethics committees, provide written or online responses to questions raised by ethics committees, drug regulatory authorities, and other institutions and collaborate with PM and the Regulatory Affairs Department on Pre-IND material preparation and follow-up question responses.
4. (Project Management) Conduct day-to-day operations of international clinical trial projects, including tracking project progress, recording and reporting issues, and coordinating and managing required resources to ensure smooth project execution.
5.(Site Management) Manage and coordinate clinical trial sites, including but not limited to participant recruitment, data monitoring, and trial logistics. Communicate fluently in English to ensure smooth progression of on-site clinical processes.
6.(Results Review) Scientifically review, analyze, and interpret clinical trial results. Compile or integrate clinical data and reports as needed.
7.(Regulatory Support) Support international marketing authorization of products, including participating in the development of registration strategies, drafting registration application dossiers, communicating with drug regulatory authorities in relevant countries and regions, and effectively addressing issues during the registration process to support product registration.
8.(Frontier Tracking) Stay abreast of innovative and forward-looking technologies and methodologies in the field of clinical trials; propose innovative trial designs and execution plans based on current project status to drive improvements in clinical trial efficiency and quality.
9.(Process Development & Optimization) Develop and optimize SOPs related to international clinical project management, lead optimization and improvement strategies for international clinical project management processes and enhance the quality and efficiency of related work by introducing new approaches and methods to improve existing processes.
10. (Collaboration) Resolve complex issues encountered during international clinical project management and provide relevant technical support and guidance. Collaborate closely with team members and other departments to ensure seamless upstream and downstream alignment.

任职资格：

1、教育背景 Education：
预防医学、公共卫生、临床医学、统计学、生命科学、生物制药等相关专业硕士学历优先。
Master's degree in relevant disciplines such as Preventive Medicine, Public Health, Clinical Medicine, Statistics, Life Sciences, or Biopharmaceuticals is preferred.
2.工作经验 Work Experience：至少5-7年临床研究、药物开发、临床试验管理等相关领域工作经验。
具有2年以上国外留学或工作经历。
At least 5–7 years of relevant work experience in clinical research, drug development, clinical trial management, or related fields.
Over 2 years of overseas study or work experience.
精通临床试验设计原则和方法学的专业知识，并能根据产品特性和临床需求制定科学合理的临床试验方案。
熟悉医学和生物学领域知识，了解疾病病理生理学、药理学和药物代谢等相关领域。
熟练进行数据分析和结论解释等。
熟悉统计学概念和方法在临床试验中的应用。
熟悉临床试验伦理及相关程序，能够确保试验活动符合伦理标准和伦理委员会的要求。
Proficient in professional knowledge of principles and methodologies of clinical trial design, with the ability to develop scientifically sound clinical trial protocols based on product characteristics and clinical needs.
Familiar with knowledge in medical and biological fields including pathophysiology, pharmacology, drug metabolism, and related fields.
Skilled in data analysis and conclusion interpretation.
Familiar with statistical concepts and methods applied in clinical trials.
Familiar with clinical trial ethics and related procedures; able to ensure trial activities comply with ethical standards and ethics committee requirements.
3.通用能力素质General Competencies：具备良好的项目统筹管理、运营和协调能力，具备良好的责任意识。
具备杰出的前瞻思维和意识，能够持续为开发和优化方案做出贡献。
出色的沟通和团队合作能力，能够与团队成员和其他部门有效协作。
具备严谨的工作态度，注重细节和实操过程的合规性。
具备自主学习和解决问题的能力，及时适应新技术和新方法。
熟悉国际临床试验法规的一般要求，如ICH-GCP和WHO通行法规要求、FDA或其他主要ICH国家的注册要求。
具备良好的英语读写能力，能够理解和撰写相关科技文献和技术报告。
具备良好的英文口语能力，可与国际合作方和国外药监进行自由沟通。
Strong capabilities in project planning, management, operations, and coordination skills, with a strong sense of responsibility.
Outstanding forward-thinking mindset and awareness, with the ability to continuously contribute to the development and optimization of protocols.
Excellent communication and teamwork skills, with the ability to collaborate effectively with team members and other departments.
Rigorous work attitude, with attention to detail and compliance in execution processes.
Self-directed learning and problem-solving capabilities, able to adapt quickly to new technologies and methodologies.
Familiar with general requirements of international clinical trial regulations, including ICH-GCP and WHO prevailing regulatory requirements, and registration requirements of the FDA or other major ICH countries.
Proficient in English reading and writing, capable of understanding and drafting relevant scientific literature and technical reports.
Fluent in spoken English, capable of freely communicating with international partners and foreign drug regulatory authorities.