1 INTRODUCTION

粤港澳大湾区国际临床试验中心（以下简称“中心”）是由深圳医学科学院计划建设的面向粤港澳大湾区、具有全球影响力的临床试验公共服务平台。

The Greater Bay Area International Clinical Trials Center (hereinafter referred to as “the Center”) is a public clinical trial service platform with global impact, established by the Shenzhen Medical Academy of Research and Translation (SMART).

粤港澳大湾区国际临床试验中心是贯彻落实《国务院关于印发〈河套深港科技创新合作区深圳园区发展规划〉的通知》（国发〔2023〕12号）的重要举措，是支持深圳建设国际科技创新中心和推进粤港澳大湾区生物医药产业高质量发展的有力支撑。中心将落户河套深港合作区，通过充分发挥河套独特的区位优势和不断叠加的政策优势，链接粤港澳大湾区临床创新资源，深化深港科技合作，搭建一站式临床试验平台，为国际国内药械研发机构提供一流临床试验技术支撑与运营管理服务。同时，中心还将发挥临床试验政策规则体系改革的“头雁”作用，推进临床试验规则和标准与国际对接，助力构建粤港澳大湾区医学科技创新联合体，提升区域生物医药产业发展竞争力。

The Center’s establishment is a key initiative aimed at implementing the "Development Plan for the Shenzhen-Hong Kong Science and Technology Innovation Cooperation Zone", issued by the State Council (State Document No. [2023] 12). It represents a crucial step in supporting Shenzhen’s efforts to become an international hub for scientific and technological innovation. It is integral to promoting the high-quality growth of the biopharmaceutical industry in the Greater Bay Area. The Center will be strategically located in the Hetao Shenzhen-Hong Kong Cooperation Zone, leveraging the area’s unique geographical and policy advantages. By connecting clinical innovation resources from across the Greater Bay Area and fostering deeper collaboration between Shenzhen and Hong Kong, the Center will establish a one-stop platform for clinical trials. This platform will provide top-tier technical and operational management services to both national and international pharmaceutical and medical device development institutions. Additionally, the Center will play a pioneering role in reforming clinical trial policies and regulations, aligning local practices with international standards. It will also facilitate the creation of a Greater Bay Area biomedical innovation alliance, and increase the region's competitiveness in global biopharmaceutical industry.

中心建设初期，设置机构服务及行政办公室、方案开发与方法学部、项目运营与质量管理部、数据技术部、政策法规办公室五个主要部门，承担临床研究服务、统筹临床研究资源、提升区域临床研究能力、创新临床研究机制、开展国际交流与合作等职能。现根据中心组建和运行工作需要，深圳医学科学院面向社会诚招临床方案开发、临床项目运营、数据技术管理等各类人才若干名。具体岗位和招聘条件如下：

In initial phase, the Center will establish five core departments: the Institutional Services and Administrative Office, the Program Development and Methodology Department, the Project Operations and Quality Management Department, the Data and Technology Department, and the Regulatory Affairs Office. These departments will be responsible for providing clinical research services, coordinating research resources, enhancing regional research capabilities, fostering innovation in clinical research, and promoting international cooperation and communication. According to the needs of the Center's construction and operations, SMART is now sincerely recruiting professionals for a variety of employment, including clinical program development, project operations, and data technology. The specific job openings and qualifications are as follows. Specific positions and recruitment conditions are as follows:

2 JOB DESCRIPTION

高管

Executive

副主任（运营）  1人

岗位职责

1. 战略规划与执行：制定并执行中心的整体运营战略，确保实现短期、中期和长期目标；

2. 资源整合与管理：统筹管理中心各部门的日常运营，优化资源配置，提高运营效率，确保研究资源的整合与高效实施；

3. 财务与风险管理：负责中心的财务管理，编制预算报告，监控资金使用，建立风险控制体系，确保财务的健康和透明；

4. 市场推广与品牌建设：领导市场推广和品牌建设活动，提升中心的国际声誉；

5. 对外合作与交流：协助中心主任建立与维护与政府机构、学术机构、医疗机构、行业组织、国际合作伙伴的关系，推动国际交流与合作，提升中心的国际影响力；

6. 资源协作与整合：协助中心主任架构临床研究协作网络，组建临床研究大PI工作站，整合粤港澳大湾区的临床研究资源，促进高效实施；

7. 创新机制建设：协助中心主任推动区域内监管机制和跨境机制创新，促进跨境数据和物资流动；

8. 完成中心主任交办的其他事项。

任职要求

1. 专业经验：拥有15年生物医药或CRO行业的管理经验，熟悉临床试验及药械研发流程，具备丰富的国际项目运营经验；

2. 领导能力：优秀的团队领导和项目管理能力，具备出色的沟通和谈判能力，能够协调各方资源，建立广泛的合作网络；

3. 教育背景：拥有MBA或相关管理领域硕士学历，国际著名管理学院求学经历者优先；

4. 政策法规：熟悉国内国际药械监管的法律法规和产业政策；

5. 行业视野：具备国际视野和经验，熟悉药械研发行业动态和技术趋势；

6. 语言能力：出色的英语技能，具备优秀的跨文化交流能力；

7. 特别优秀者，可适当放宽任职条件。

Deputy Director (Operations)

1 position available

Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC

Job Description:

We are hiring a experienced Deputy Director (Operations) to lead the strategic direction and day-to-day operations of our world-class clinical trials center.

The Operations Director will optimize resources, manage finances, and drive international branding and partnerships

This role will play a pivotal role in shaping the future of the center by fostering collaboration and integrating clinical research resources in the Greater Bay Area.

Key Responsibilities:

1. Develop and execute the center's operational strategy to achieve its short, medium, and long-term goals.

2. Manage daily operations, improve efficiency, and optimize resource allocation.

3. Oversee financial management, including budgeting, risk control, and transparency.

4. Lead marketing and branding initiatives to enhance the center’s international reputation.

5. Foster international partnerships with government, academic, medical, and industry organizations.

Requirements:

1. 15+ years of management experience in the bio-pharmaceutical or CRO industry with a deep understanding of clinical trials and pharmaceutical R&D processes.15+ years of management experience in the bio-pharmaceutical or CRO industry with a deep understanding of clinical trials and pharmaceutical R&D processes.

2. Strong leadership, project management, and communication skills.

3. Master’s degree in MBA or a related management field (preferably from a globally recognized institution).

4. Familiar with both domestic and international regulations governing pharmaceuticals and medical devices.

5. Proficient in English with strong cross-cultural communication skills.

6. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.

副主任（技术）  1人

岗位职责

1. 技术平台与管理体系建设：规划和管理中心的临床试验技术和信息化支持平台，建立高效的技术服务流程和质量管理体系；

2. 技术服务与支持：提供策略咨询与预评估服务，支持合同研究服务，确保项目的技术可行性；

3. 创新与优化：开发创新的药械临床试验工具，建设试验参与者准备队列，推动伦理审查优化和新型临床试验设计，提升研究效率和质量；

4. 人才培养与培训：协助中心主任建设临床研究培训平台，为区域内培养具有国际视野和高水平研究能力的领军人才与科研队伍；

5. 团队领导与发展：协助中心主任领导多学科临床试验技术团队，确保服务符合国际标准，推动临床研究能力提升；

6. 完成中心主任交办的其他事项。

任职要求

1. 专业经验：拥有15年临床试验领域的技术从业经验，且具备丰富的技术管理经验；

2. 领导能力：优秀的团队领导和项目管理能力，能有效带领技术团队完成跨区域复杂项目；

3. 教育背景：医学或药学博士学历，有国外求学研究经历者优先；

4. 政策法规：熟悉国际临床试验标准和法规，具有推动技术创新和转化应用的成功案例者优先；

5. 行业视野：具备国际视野和经验，熟悉药械研发行业动态和技术趋势；

6. 语言能力：出色的英语技能，具备优秀的跨文化交流能力；

7. 特别优秀者，可适当放宽任职条件。

Deputy Director (Technical)

1 position available

Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC

Job Description:

We are hiring an experienced Deputy Director (Technical) to oversee the development of the center’s clinical trial technology and IT platforms.

The Technical Director will ensure the implementation of high-quality technical services and innovative tools for clinical trials.

This role will also play a crucial part in training future leaders and building a multidisciplinary technical team.

Key Responsibilities:

1. Plan and manage the technical platform and information systems for clinical trials.

2. Provide strategic consulting, technical support, and ensure the feasibility of research projects.

3. Lead the development of innovative tools for clinical trials and optimize research design.

4. Foster and lead a high-performing technical team, ensuring adherence to international standards.

Requirements:

1. 15+ years of technical experience in clinical trials and technical management, with the ability of leading cross-regional complex projects.

2. PhD in Medicine or Pharmacy, with international study or research experience is preferred.

3. Familiar with international clinical trial standards and regulations.

4. Proficient in English with strong leadership and cross-cultural communication skills.

5. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.

机构服务及行政办公室

Institutional Services and Administrative Office

行政服务办公室总监  1人

岗位职责

1. 负责行政管理体系的建立、维护和优化，参与制定行政管理政策和流程，并监督执行；

2. 组织和协调中心行政相关会议和活动，确保顺利进行；负责组织各类培训活动和人才培养项目；

3. 建设和管理行政团队，提升团队的专业能力和工作效率；

4. 与外部机构建立和维护良好的关系，处理相关行政事务；

5. 完成上级交办的其他工作。

任职要求

1. 专业经验：具有10年大型企业或医药行业的行政管理经验，有行政总监或相当职位的工作经验者优先；

2. 领导能力：具备优秀的团队管理、领导和组织协调能力，具备解决复杂问题的能力，能够带领行政团队高效完成工作；

3. 教育背景；硕士以上学历，行政管理、人力资源管理、工商管理或相关专业者优先；

4. 语言能力：具备在英文环境下胜任岗位职责的能力。

5. 特别优秀者，可适当放宽任职条件。

Director of Administrative Services

1 position available

Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC

Job Description:

We are hiring a Director of Administrative Services to establish and optimize the center’s administrative systems.

The Director of Administrative Services involves organizing key events and meetings, leading the administrative team, and maintaining relationships with external agencies.

This role will play a crucial role in ensuring operational efficiency and supporting talent development within the Center.

Key Responsibilities:

1. Establish, maintain, and optimize the administrative management system.

2. Organize and coordinate administrative meetings, events, and training programs.

3. Lead and develop the administrative team to enhance professional skills and efficiency.

4. Build and maintain strong relationships with external agencies and handle administrative tasks.

Requirements:

1. 10+ years of experience in administrative roles, preferably in large enterprises or the pharmaceutical industry.

2. Strong team leadership, problem-solving, and organizational skills.

3. Master’s degree in Administration, Human Resource Management, Business Administration or related fields.

4. Fluent in English with the ability to perform effectively in an English-speaking environment.

5. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.

综合行政岗  若干人

岗位职责

配合部门负责人，具体负责综合行政工作。

任职要求

1. 教育背景：具有硕士及以上学历，专业背景不限；

2. 工作经验：具有3年以上企事业单位相关岗位工作经历，具有履行岗位职责所必需的专业知识和工作技能；

3. 组织协调：具有一定的沟通、协调、组织管理等能力，具有基本的公文写作能力；

4. 语言能力：良好的英文读写能力。

General Administrative Officer

Multiple positions available

Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC

Job Description:

We are hiring General Administrative Officers to assist the department head with daily administrative duties.

You will play a key role in coordinating organizational activities and ensuring the smooth operation of the center’s administrative processes.

Key Responsibilities:

1. Assist the department head with comprehensive administrative tasks.

2. Manage communication, coordination, and organization of internal and external activities.

3. Handle administrative documentation, including drafting and reviewing documents.

4. Support the organization of meetings and events.

Requirements:

1. Education: Master’s degree or above, any field of study.

2. Experience: Minimum of 3 years in administrative roles within corporate or public institutions.

3. Skills: Strong organizational, coordination, and document writing skills.

4. Language: Good in English Writing and Speaking.

方案开发与方法学部

Program Development and Methodology Department

方案开发与方法学部总监  1人

岗位职责

1. 根据中心总体规划目标，组建方案开发与方法学平台，并组织开展业务工作；

2. 负责组织制定中心方案开发与生物统计业务工作制度、规章、操作标准等规范，并监督实施；

3. 组织对部门人员进行专业培训、指导与考核，参与部门人员招聘；

4. 负责组织部门开展与临床试验项目方案开发、统计分析工作，并在计划时间内高质量地完成；

5. 负责组织建立、维护与相关专业领域专家的良好关系，就方案开发与统计分析中遇到的专业问题与专家进行沟通咨询；

6. 负责就部门业务与中心其他相关部门进行沟通和协调，组织部门对中心其他部门提供及时、高效的技术支持；

7. 完成上级交办的其他工作。

任职要求

1. 专业经验：具有在生物医药或CRO行业10年项目开发或方法学平台工作经验，3年部门管理的工作经验，精通临床试验设计；

2. 领导能力：具有出色的领导和执行力，以及优秀的沟通、培训和演讲技能；

3. 教育背景：医学或药学博士学历；

4. 政策法规：熟悉国内国际药械监管的法律法规和产业政策；

5. 行业视野：熟悉国内外药物研究发展和现状；

6. 语言能力：具备在英语环境下胜任岗位职责的能力；

7. 特别优秀者，可适当放宽任职条件。

Director of Program Development & Methodology

1 position available

Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC

Job Description:

We are hiring a Director of Program Development & Methodology to build and lead the program development and methodology platform for the Center.

This role will involve overseeing clinical trial design, statistical analysis, and ensuring timely and high-quality project execution.

Key Responsibilities:

1. Establish and manage the program development and methodology platform.

2. Develop and implement regulatory and operational standards for program development and bio-statistics.

3. Lead training, recruitment, and assessment of departmental personnel.

4. Oversee clinical trial protocol development and statistical analysis.

5. Maintain relationships with industry experts to address complex project issues.

Requirements:

1. 10+ years of experience in project development or methodology within the bio-pharmaceutical or CRO industry.

2. Strong leadership and execution skills, with excellent communication and presentation abilities.

3. PhD in Medicine or Pharmacy.

4. Familiar with domestic and international regulations governing drug and device development.

5. Fluent in English with the ability to perform duties in an English-speaking environment.

6. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.

统计师  若干人

岗位职责

1. 负责制定临床研究统计计划，完成临床试验方案中的统计部份设计，包括样本量计算、随机和编盲、统计分析计划等；

2. 参与方案讨论会，并提供统计支持；

3. 临床数据统计分析与报告审核；

4. 临床研究统计部分供应商管理，审核或独立撰写统计分析计划，可独立进行研究数据的资料处理和统计分析；

5. 能在工作中使用SAS等软件进行统计分析程序编写，进行一定的数据挖掘和分析；

6. 能参与学术交流及药物审评讨论。

任职要求

1. 教育背景：硕士及以上学历，生物统计、医学统计等相关专业；

2. 工作经验：独立完成过临床数据收集、整理、挖掘分析工作；熟悉临床试验设计与统计分析流程，2年以上相关经验；

3. 专业技能：熟悉国内外临床试验相关的生物统计学技术指导原则，熟练运用临床试验常规统计软件；

4. 其他条件：有较强的逻辑性、强烈的团队合作意识与责任感，有较强的英文阅读原文和写作的能力。

Bio-statistician

Multiple positions available

Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC

Job Description:

We are hiring Bio-statisticians to design and manage statistical plans for clinical research projects.

This role will contribute to the development of clinical trial protocols, provide statistical analysis, and manage vendor relationships.

Key Responsibilities:

1. Develop and execute statistical plans for clinical trials, including sample size calculation, randomization, and blinding.

2. Provide statistical support during protocol discussions and meetings.

3. Conduct data analysis and review statistical reports.

4. Manage and oversee vendors handling statistical portions of clinical trials.

5. Utilize statistical software (e.g. SAS) for data mining, analysis, and reporting.

Requirements:

1. Education: Master’s degree or above in Bio-statistics, Medical Statistics or related fields.

2. Experience: 2+ years of experience in clinical trial design and statistical analysis.

3. Skills: Proficient in using statistical software and familiar with domestic and international biostatistical technical guidelines related to clinical trials. With strong logic and responsibility in work.

4. Language: Fluent in English Reading and Writing.

项目运营与质量管理部

Project Operations and Quality Management Department

项目运营与质量管理部总监  1人

岗位职责

1. 根据中心总体规划目标，组建项目运营与质量管理部门，并组织开展业务工作；

2. 负责组织制定中心临床运营、项目管理、临床监察、质量保证和质量控制等临床研究实施各环节的工作制度、规章、操作标准等规范，并监督实施；

3. 组织对部门人员进行专业培训、指导与考核，参与部门人员招聘；

4. 协调与各临床研究中心的合作关系，保持与各中心的主要研者进行良性的互动；与涉及的药政法规监管部门，医学领域专家、科研院所等相关部门，建立并保持交流和沟通的渠道；

5. 完成上级交办的其他工作。

任职要求

1. 专业经验：在制药企业或临床CRO公司至少10年临床运营、临床监察或相关工作经验，3年部门管理的工作经验，广泛的医院网络资源，熟悉临床试验运营；

2. 教育背景：临床医学、临床药学、药事管理等相关专业硕士或以上学历；

3. 政策法规：熟悉国内国际药械监管的法律法规，及临床试验流程；

4. 语言能力：具备在英语环境下胜任岗位职责的能力；

5. 特别优秀者，可适当放宽任职条件。

Director of Project Operations & Quality Management

1 position available

Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC

Job Description:

We are hiring a Director of Project Operations & Quality Management to establish and lead the project operations and quality management department.

This role will oversee clinical trial operations, ensure compliance with quality standards, and foster relationships with clinical research centers and regulatory bodies.

Key Responsibilities:

1. Develop and lead the Project Operations & Quality Management Department.

2. Formulate and implement regulations, operation standards, and quality assurance processes for clinical research.

3. Provide training and guidance for the department’s personnel and lead recruitment efforts.

4. Build strong collaborative relationships with clinical research centers, regulatory bodies, and industry experts.

Requirements:

1. 10+ years of experience in clinical operations or monitoring within pharmaceutical companies or CROs.

2. 3+ years of experience in departmental management with strong hospital network resources.

3. Master’s degree or above in Clinical Medicine, Clinical Pharmacy, or related fields.

4. Familiar with both domestic and international regulations governing clinical trials and drugs/ medical devices development.

5. Fluent in English with strong cross-cultural communication skills.

6. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.

临床监查员  若干人

岗位职责

1. 负责临床试验的具体实施和监查工作，确保项目按照国家GCP要求、试验方案和中心标准操作程序进行，做好全过程的质量控制；

2. 负责整理和完善所有试验文档与资料，试验用药物和物品的正确保管、发放和使用；

3. 检查并报告试验进度和质量、病例报告表填写、不良事件等各方面情况，对试验研究过程中的不良事件和严重不良事件进行跟踪，保障受试者权益和中心利益；

4. 定期归纳并提交监查报告，填写相关报告及试验记录，确保数据真实准确、完整无误；

5. 协调各研究中心、数据管理人员之间的沟通，培养并保持良好的关系；

6. 完成上级交办的其它工作。

任职要求

1. 教育背景：药学或医学相关专业本科及以上学历；

2. 工作经验：至少1年CRO行业或药企CRA工作经验；

3. 专业技能：熟悉药品注册管理办法、药品临床试验及GCP等相关法规；

4. 语言能力：良好的英文读写能力；

5. 其他条件：有良好的人际关系和良好的沟通及语言表达能力。

Clinical Research Associate

Multiple positions available

Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC

Job Description:

We are hiring detail-oriented Clinical Research Associates (CRA) to monitor and ensure the proper conduct of clinical trials.

This role will ensure compliance with GCP guidelines, manage trial documentation, and oversee the safety and efficacy of trial procedures.

Key Responsibilities:

1. Monitor clinical trials to ensure they are conducted in compliance with GCP guidelines, trial protocols, and SOPs.

2. Manage trial documents, including the distribution and storage of investigational drugs and trial supplies.

3. Track and report trial progress, adverse events, and ensure proper case report form completion.

4. Coordinate communication between research centers and data management personnel.

5. Submit detailed monitoring reports and maintain accurate trial records.

Requirements:

1. Education: Bachelor’s degree or above in Pharmacy, Medicine or related fields.

2. Experience: Minimum of 1 year of experience as a CRA within a CRO or pharmaceutical company.

3. Skills: In-depth knowledge of GCP guidelines and clinical trial regulations.

4. Language: Good in English Writing and Speaking.

5. Other: Good at maintain relationship and communication skills.

数据技术部

Data Technology Department

数据技术部总监  1人

岗位职责

1. 负责部门组建及团队的规划与建设，并组织开展业务工作；

2. 负责中心网站、信息化办公系统、医研企协作平台、临床试验数据管理平台的建设与维护，确保临床研究数据库安全；

3. 监督和管理临床研究项目数据管理的相关活动，并对数据质量负责；

4. 负责团队内的人员管理管理工作，对下级进行培养和考核；

5. 完成领导交办的其他工作。

任职要求

1. 专业经验：10年或以上相关工作经历，有制药企业或CRO公司团队管理经验者优先。

2. 教育背景：统计、信息/计算机等相关专业，硕士或以上学历。

3. 政策法规：熟悉国内国际药械监管的法律法规，及临床试验流程，熟悉临床试验数据管理相关国际标准；

4. 语言能力：具备在英语环境下胜任岗位职责的能力；

5. 特别优秀者，可适当放宽任职条件。

Director of Data Technology

1 position available

Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC

Job Description:

We are hiring a Director of Data Technology to lead the development and management of the center’s data platforms, including clinical trial data management and IT infrastructure.

This role will ensure the security and quality of clinical research data and lead a team in maintaining cutting-edge data management practices.

Key Responsibilities:

1. Develop and maintain the center's website, information technology systems, and clinical trial data management platform.

2. Supervise data management activities for clinical research projects and ensure data quality.

3. Lead and manage the data technology team to meet international standards.

4. Ensure the security and proper handling of clinical trial databases.

Requirements:

1. 10+ years of experience in data management, preferably in pharmaceutical or CRO companies.

2. Strong team leadership and project management skills.

3. Master’s degree in Statistics, Information Technology, Computer Science or related fields.

4. Familiar with international standards for clinical trial data management.

5. Fluent in English with strong communication skills.

6. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.

数据工程师  若干人

岗位职责

1. 负责中心数据管理系统的日常维护和优化，确保数据的准确性和安全性。

2. 参与数据采集、处理和分析流程的设计和实施，提高数据处理效率。

3. 与项目团队协作，为临床研究提供数据技术支持，确保数据的合规性和一致性。

4. 监控数据管理系统的性能，及时发现并解决技术问题。

5. 参与制定和更新数据管理的标准操作流程 (SOPs)，协助进行数据管理系统的升级和新技术的集成。

6. 为内部员工提供数据管理相关的培训和技术支持。

任职要求

1. 教育背景：计算机科学、信息技术或相关领域的本科及以上学历；

2. 工作经验：至少2年的信息技术或数据技术工作经验；

3. 专业技能：熟悉数据库管理，了解临床研究数据管理的法规和指南；

4. 其他条件：具备良好的分析问题和解决问题的能力，能够独立工作；优秀的沟通技巧，能够与非技术人员有效沟通技术问题。

Data Engineer

Multiple positions available

Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC

Job Description:

We are hiring skilled Data Engineers to maintain and optimize the center’s data management system.

This role will collaborate with project teams to provide data support for clinical research and ensure data accuracy and security.

Key Responsibilities:

1. Responsible for the daily maintenance and optimization of the Center’s data management system, ensuring data accuracy and security.

2. Participate in the design and implementation of data collection and management processes to improve data processing efficiency.

3. Collaborate with project teams to provide technical support for clinical research, ensuring data compliance and consistency.

4. Monitor the performance of the data management system, identifying and resolving technical issues promptly.

5. Assist in the development and updating of standard operating procedures (SOPs) for data management, and support system upgrades and the integration of new technologies.

6. Provide training and technical support on data management to internal staff.

Requirements:

1. Education: Bachelor’s degree or above in Computer Science, Information Technology or related fields.

2. Experience: Minimum of 2 years of experience in information technology or data management.

3. Skills: Familiarity with database management and knowledge of regulations and guidelines related to clinical research data management.

4. Other: Strong analytical and problem-solving skills, with the ability to work independently; excellent communication skills, able to explain technical issues to non-technical staff effectively.

政策法规办公室

Regulatory Affairs Office

政策法规办公室总监  1人

岗位职责

1. 紧密跟踪国内外（中国、美国、欧洲等）药事注册相关法规和技术规范，及法规要求的最新动态；及时捕捉、解读并反馈注册相关政策的更新对于中心业务运营及战略实施的影响，为中心决策提供建议，以确保中心的产品开发活动及相关研究的监管合规性；

2. 为其他部门提供注册法规指导及支持，指导中心项目研发合规开展；

3. 建立和优化注册法规事务相关内部规章制度和工作流程，在项目研发、申报、审批过程中，与内部各部门、外部检测机构、临床机构等各合作单位保持良好的沟通和管理工作，确保内外部各部门各单位的工作符合注册相关监管法规的要求；

4. 建立与国内外监管和审评审批部门的良好关系，推动相关政策创新与落地；

5. 完成上级交办的其它工作。

任职要求

1. 专业经验：10年以上药品注册申报工作经历，熟悉药品研究开发全过程和药品注册相关法规，熟悉国际申报的流程与政策要求，有国际制药公司注册管理工作经验优先；

2. 教育背景：临床医学、临床药学、药事管理等相关专业硕士或以上学历；

3. 语言能力：具备在英语环境下胜任岗位职责的能力；

4. 特别优秀者，可适当放宽任职条件。

Director of Regulatory Affairs

1 position available

Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC

Job Description:

We are hiring a Director of Regulatory Affairs to oversee regulatory compliance for the center's drug development and registration processes.

This role will involve close tracking of international regulatory updates, providing guidance to internal teams, and maintaining relationships with domestic and international regulatory authorities.

Key Responsibilities:

1. Monitor and interpret regulatory updates from China, the U.S., Europe, and other regions.

2. Provide regulatory guidance to other departments to ensure compliance in drug development and registration.

3. Establish and optimize internal regulatory processes and workflows.

4. Maintain strong relationships with domestic and international regulatory bodies to support policy innovation and approval processes.

Requirements:

1. 10+ years of experience in drug registration and regulatory affairs, with a deep understanding of drug development and international regulatory requirements.

2. Experience working in international pharmaceutical companies is preferred.

3. Master’s degree in Clinical Medicine, Pharmacy or related fields.

4. Fluent in English with the ability to perform regulatory duties in an English-speaking environment.

5. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.

政策法规专员  若干人

岗位职责

1. 参与注册项目的计划、准备及执行，确保项目成功注册；

2. 编制注册申请资料并准备其他法规文件，确保经内部审阅和批准之后的资料及时递交；

3. 维护注册文件的存档；

4. 关注法规的变化，确保所提交的资料是符合法规要求的并且适用于不断变化的法规。

任职要求

1. 教育背景：药学或医学相关专业硕士及以上学历；

2. 工作经验：1-3年CRO或制药公司工作经验，第三方实验机构或注册工作经验优先；

3. 专业技能：擅长文案工作，对相关注册法规有一定的了解；

4. 语言能力：具有较好的中英文口语/书面沟通能力；

5.其他条件：熟练掌握计算机操作，熟练掌握Office办公软件。

Regulatory Affairs Specialist

Multiple positions available

Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC

Job Description:

We are hiring meticulous Regulatory Affairs Specialists to manage regulatory submissions and ensure compliance with global regulations.

This job will assist in preparing and submitting regulatory documents and maintain up-to-date knowledge of regulatory changes.

Key Responsibilities:

1. Plan, prepare, and execute regulatory submissions for clinical trials and drug registrations.

2. Compile and submit regulatory documents, ensuring compliance with the latest requirements.

3. Archive and maintain regulatory documents and files.

4. Stay up-to-date with regulatory changes and ensure submission materials are compliant with evolving regulations.

Requirements:

1. Education: Master’s degree in Pharmacy, Medicine or related fields.

2. Experience: 1-3 years of experience in regulatory affairs, preferably within a CRO or pharmaceutical company.

3. Skills: Strong writing and document preparation skills; good understanding of regulatory guidelines.

4. Language: Fluent in both Chinese and English Speaking and Writing.

5. Other: Good at office suites.

3 JOB APPLICATION

如果您对以上发布的职位感兴趣，请发送个人中文或英文简历(PDF)至recruitment@smart.org.cn, 邮件主题为“岗位名称-姓名-专业-高校人才网” 【快捷投递：点击下方“立即投递/投递简历”，即刻进行职位报名】；或登陆https://smart.org.cn/recruit/administrative-support/index.html搜索岗位直接投递。

If you’re interested in any role posted, please send your Chinese or English resume (PDF) to recruitment@smart.org.cn, with email subject template as “Job title - Name - Academic Specialty”. Or you can apply directly through https://smart.org.cn/recruit/administrative-support/index.html.