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).
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.
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:
1.Deputy Director (Operations)
(1 position available)
Job Description:We are hiring an experienced Deputy Director (Operations) to lead the strategic direction and day-to-day operations of our 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 and maintain 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.
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 service may be appropriately relaxed for those who are particularly outstanding.
2.Deputy Director (Technical)
(1 position available)
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 degreed in Medicine or Pharmacy, with the experience of studied and/or researched abroad 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.
3.Director of Administrative Services
(1 position available)
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. Foster 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.
4.General Administrative Officer
(Multiple positions available)
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. Work on 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 organization, coordination, and document writing skills.
4. Language: Good in English Writing and Speaking
5.Director of Program Development & Methodology
(1 position available)
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 degreed in Medicine or Pharmacy.
4. Familiar with domestic and international regulations governing drugs and medical devices 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.
6.Bio-statistician
(Multiple positions available)
Job Description:
We are hiring Bio-statisticians to design and manage statistical plans for clinical research projects. In this role, you 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 seminars.
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.
6. Participate in academic communication and drug review discussions.
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 internationalbiostatistical technical guidelines related to clinical trials. With strong logic and responsibility in work
4. Language: Fluent in English Reading and Writing.
7.Director of Project Operations & Quality Management
(1 position available)
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.
8.Clinical Research Associate
(Multiple positions available)
Job Description:
We are hiring detail-oriented Clinical Research Associates (CRA) to monitor and ensure the proper conduct of clinical trials.
You 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.
9.Director of Data Technology
(1 position available)
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.
10.Data Engineer
(Multiple positions available)
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. Educational: Bachelor’s degree or higher in Computer Science, Information Technology or a related field.
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.
11.Director of Regulatory Affairs
(1 position available)
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 of 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.
12. Regulatory Affairs Specialist
(Multiple positions available)
Job Description:
We are hiring for meticulous Regulatory Affairs Specialists to manage regulatory submissions and ensure compliance with global regulations.
This role 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 Microsoft Office.