1 INTRODUCTION
粵港澳大灣區(qū)國際臨床試驗中心（以下簡稱“中心”）是由深圳醫(yī)學(xué)科學(xué)院計劃建設(shè)的面向粵港澳大灣區(qū)、具有全球影響力的臨床試驗公共服務(wù)平臺。
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).
粵港澳大灣區(qū)國際臨床試驗中心是貫徹落實《國務(wù)院關(guān)于印發(fā)〈河套深港科技創(chuàng)新合作區(qū)深圳園區(qū)發(fā)展規(guī)劃〉的通知》（國發(fā)〔2023〕12號）的重要舉措，是支持深圳建設(shè)國際科技創(chuàng)新中心和推進粵港澳大灣區(qū)生物醫(yī)藥產(chǎn)業(yè)高質(zhì)量發(fā)展的有力支撐。中心將落戶河套深港合作區(qū)，通過充分發(fā)揮河套獨特的區(qū)位優(yōu)勢和不斷疊加的政策優(yōu)勢，鏈接粵港澳大灣區(qū)臨床創(chuàng)新資源，深化深港科技合作，搭建一站式臨床試驗平臺，為國際國內(nèi)藥械研發(fā)機構(gòu)提供一流臨床試驗技術(shù)支撐與運營管理服務(wù)。同時，中心還將發(fā)揮臨床試驗政策規(guī)則體系改革的“頭雁”作用，推進臨床試驗規(guī)則和標準與國際對接，助力構(gòu)建粵港澳大灣區(qū)醫(yī)學(xué)科技創(chuàng)新聯(lián)合體，提升區(qū)域生物醫(yī)藥產(chǎn)業(yè)發(fā)展競爭力。
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
中心建設(shè)初期，設(shè)置機構(gòu)服務(wù)及行政辦公室、方案開發(fā)與方法學(xué)部、項目運營與質(zhì)量管理部、數(shù)據(jù)技術(shù)部、政策法規(guī)辦公室五個主要部門，承擔(dān)臨床研究服務(wù)、統(tǒng)籌臨床研究資源、提升區(qū)域臨床研究能力、創(chuàng)新臨床研究機制、開展國際交流與合作等職能?，F(xiàn)根據(jù)中心組建和運行工作需要，深圳醫(yī)學(xué)科學(xué)院面向社會誠招臨床方案開發(fā)、臨床項目運營、數(shù)據(jù)技術(shù)管理等各類人才若干名。具體崗位和招聘條件如下：
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
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（技術(shù)） 1人
崗位職責(zé)
1. 技術(shù)平臺與管理體系建設(shè)：規(guī)劃和管理中心的臨床試驗技術(shù)和信息化支持平臺，建立高效的技術(shù)服務(wù)流程和質(zhì)量管理體系；
2. 技術(shù)服務(wù)與支持：提供策略咨詢與預(yù)評估服務(wù)，支持合同研究服務(wù)，確保項目的技術(shù)可行性；
3. 創(chuàng)新與優(yōu)化：開發(fā)創(chuàng)新的藥械臨床試驗工具，建設(shè)試驗參與者準備隊列，推動倫理審查優(yōu)化和新型臨床試驗設(shè)計，提升研究效率和質(zhì)量；
4. 人才培養(yǎng)與培訓(xùn)：協(xié)助中心主任建設(shè)臨床研究培訓(xùn)平臺，為區(qū)域內(nèi)培養(yǎng)具有國際視野和高水平研究能力的領(lǐng)軍人才與科研隊伍；
5. 團隊領(lǐng)導(dǎo)與發(fā)展：協(xié)助中心主任領(lǐng)導(dǎo)多學(xué)科臨床試驗技術(shù)團隊，確保服務(wù)符合國際標準，推動臨床研究能力提升；
6. 完成中心主任交辦的其他事項。
任職要求
1. 專業(yè)經(jīng)驗：擁有15年臨床試驗領(lǐng)域的技術(shù)從業(yè)經(jīng)驗，且具備豐富的技術(shù)管理經(jīng)驗；
2. 領(lǐng)導(dǎo)能力：優(yōu)秀的團隊領(lǐng)導(dǎo)和項目管理能力，能有效帶領(lǐng)技術(shù)團隊完成跨區(qū)域復(fù)雜項目；
3. 教育背景：醫(yī)學(xué)或藥學(xué)博士學(xué)歷，有國外求學(xué)研究經(jīng)歷者優(yōu)先；
4. 政策法規(guī)：熟悉國際臨床試驗標準和法規(guī)，具有推動技術(shù)創(chuàng)新和轉(zhuǎn)化應(yīng)用的成功案例者優(yōu)先；
5. 行業(yè)視野：具備國際視野和經(jīng)驗，熟悉藥械研發(fā)行業(yè)動態(tài)和技術(shù)趨勢；
6. 語言能力：出色的英語技能，具備優(yōu)秀的跨文化交流能力；
7. 特別優(yōu)秀者，可適當(dāng)放寬任職條件。
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.
機構(gòu)服務(wù)及行政辦公室
Institutional Services and Administrative Office
行政服務(wù)辦公室總監(jiān) 1人
崗位職責(zé)
1. 負責(zé)行政管理體系的建立、維護和優(yōu)化，參與制定行政管理政策和流程，并監(jiān)督執(zhí)行；
2. 組織和協(xié)調(diào)中心行政相關(guān)會議和活動，確保順利進行；負責(zé)組織各類培訓(xùn)活動和人才培養(yǎng)項目；
3. 建設(shè)和管理行政團隊，提升團隊的專業(yè)能力和工作效率；
4. 與外部機構(gòu)建立和維護良好的關(guān)系，處理相關(guān)行政事務(wù)；
5. 完成上級交辦的其他工作。
任職要求
1. 專業(yè)經(jīng)驗：具有10年大型企業(yè)或醫(yī)藥行業(yè)的行政管理經(jīng)驗，有行政總監(jiān)或相當(dāng)職位的工作經(jīng)驗者優(yōu)先；
2. 領(lǐng)導(dǎo)能力：具備優(yōu)秀的團隊管理、領(lǐng)導(dǎo)和組織協(xié)調(diào)能力，具備解決復(fù)雜問題的能力，能夠帶領(lǐng)行政團隊高效完成工作；
3. 教育背景；碩士以上學(xué)歷，行政管理、人力資源管理、工商管理或相關(guān)專業(yè)者優(yōu)先；
4. 語言能力：具備在英文環(huán)境下勝任崗位職責(zé)的能力。
5. 特別優(yōu)秀者，可適當(dāng)放寬任職條件。
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.
方案開發(fā)與方法學(xué)部
Program Development and Methodology Department
方案開發(fā)與方法學(xué)部總監(jiān) 1人
崗位職責(zé)
1. 根據(jù)中心總體規(guī)劃目標，組建方案開發(fā)與方法學(xué)平臺，并組織開展業(yè)務(wù)工作；
2. 負責(zé)組織制定中心方案開發(fā)與生物統(tǒng)計業(yè)務(wù)工作制度、規(guī)章、操作標準等規(guī)范，并監(jiān)督實施；
3. 組織對部門人員進行專業(yè)培訓(xùn)、指導(dǎo)與考核，參與部門人員招聘；
4. 負責(zé)組織部門開展與臨床試驗項目方案開發(fā)、統(tǒng)計分析工作，并在計劃時間內(nèi)高質(zhì)量地完成；
5. 負責(zé)組織建立、維護與相關(guān)專業(yè)領(lǐng)域?qū)＜业牧己藐P(guān)系，就方案開發(fā)與統(tǒng)計分析中遇到的專業(yè)問題與專家進行溝通咨詢；
6. 負責(zé)就部門業(yè)務(wù)與中心其他相關(guān)部門進行溝通和協(xié)調(diào)，組織部門對中心其他部門提供及時、高效的技術(shù)支持；
7. 完成上級交辦的其他工作。
任職要求
1. 專業(yè)經(jīng)驗：具有在生物醫(yī)藥或CRO行業(yè)10年項目開發(fā)或方法學(xué)平臺工作經(jīng)驗，3年部門管理的工作經(jīng)驗，精通臨床試驗設(shè)計；
2. 領(lǐng)導(dǎo)能力：具有出色的領(lǐng)導(dǎo)和執(zhí)行力，以及優(yōu)秀的溝通、培訓(xùn)和演講技能；
3. 教育背景：醫(yī)學(xué)或藥學(xué)博士學(xué)歷；
4. 政策法規(guī)：熟悉國內(nèi)國際藥械監(jiān)管的法律法規(guī)和產(chǎn)業(yè)政策；
5. 行業(yè)視野：熟悉國內(nèi)外藥物研究發(fā)展和現(xiàn)狀；
6. 語言能力：具備在英語環(huán)境下勝任崗位職責(zé)的能力；
7. 特別優(yōu)秀者，可適當(dāng)放寬任職條件。
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.
統(tǒng)計師 若干人
崗位職責(zé)
1. 負責(zé)制定臨床研究統(tǒng)計計劃，完成臨床試驗方案中的統(tǒng)計部份設(shè)計，包括樣本量計算、隨機和編盲、統(tǒng)計分析計劃等；
2. 參與方案討論會，并提供統(tǒng)計支持；
3. 臨床數(shù)據(jù)統(tǒng)計分析與報告審核；
4. 臨床研究統(tǒng)計部分供應(yīng)商管理，審核或獨立撰寫統(tǒng)計分析計劃，可獨立進行研究數(shù)據(jù)的資料處理和統(tǒng)計分析；
5. 能在工作中使用SAS等軟件進行統(tǒng)計分析程序編寫，進行一定的數(shù)據(jù)挖掘和分析；
6. 能參與學(xué)術(shù)交流及藥物審評討論。
任職要求
1. 教育背景：碩士及以上學(xué)歷，生物統(tǒng)計、醫(yī)學(xué)統(tǒng)計等相關(guān)專業(yè)；
2. 工作經(jīng)驗：獨立完成過臨床數(shù)據(jù)收集、整理、挖掘分析工作；熟悉臨床試驗設(shè)計與統(tǒng)計分析流程，2年以上相關(guān)經(jīng)驗；
3. 專業(yè)技能：熟悉國內(nèi)外臨床試驗相關(guān)的生物統(tǒng)計學(xué)技術(shù)指導(dǎo)原則，熟練運用臨床試驗常規(guī)統(tǒng)計軟件；
4. 其他條件：有較強的邏輯性、強烈的團隊合作意識與責(zé)任感，有較強的英文閱讀原文和寫作的能力。
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
項目運營與質(zhì)量管理部
Project Operations and Quality Management Department
項目運營與質(zhì)量管理部總監(jiān) 1人
崗位職責(zé)
1. 根據(jù)中心總體規(guī)劃目標，組建項目運營與質(zhì)量管理部門，并組織開展業(yè)務(wù)工作；
2. 負責(zé)組織制定中心臨床運營、項目管理、臨床監(jiān)察、質(zhì)量保證和質(zhì)量控制等臨床研究實施各環(huán)節(jié)的工作制度、規(guī)章、操作標準等規(guī)范，并監(jiān)督實施；
3. 組織對部門人員進行專業(yè)培訓(xùn)、指導(dǎo)與考核，參與部門人員招聘；
4. 協(xié)調(diào)與各臨床研究中心的合作關(guān)系，保持與各中心的主要研者進行良性的互動；與涉及的藥政法規(guī)監(jiān)管部門，醫(yī)學(xué)領(lǐng)域?qū)＜?、科研院所等相關(guān)部門，建立并保持交流和溝通的渠道；
5. 完成上級交辦的其他工作。
任職要求
1. 專業(yè)經(jīng)驗：在制藥企業(yè)或臨床CRO公司至少10年臨床運營、臨床監(jiān)察或相關(guān)工作經(jīng)驗，3年部門管理的工作經(jīng)驗，廣泛的醫(yī)院網(wǎng)絡(luò)資源，熟悉臨床試驗運營；
2. 教育背景：臨床醫(yī)學(xué)、臨床藥學(xué)、藥事管理等相關(guān)專業(yè)碩士或以上學(xué)歷；
3. 政策法規(guī)：熟悉國內(nèi)國際藥械監(jiān)管的法律法規(guī)，及臨床試驗流程；
4. 語言能力：具備在英語環(huán)境下勝任崗位職責(zé)的能力；
5. 特別優(yōu)秀者，可適當(dāng)放寬任職條件。
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.
臨床監(jiān)查員 若干人
崗位職責(zé)
1. 負責(zé)臨床試驗的具體實施和監(jiān)查工作，確保項目按照國家GCP要求、試驗方案和中心標準操作程序進行，做好全過程的質(zhì)量控制；
2. 負責(zé)整理和完善所有試驗文檔與資料，試驗用藥物和物品的正確保管、發(fā)放和使用；
3. 檢查并報告試驗進度和質(zhì)量、病例報告表填寫、不良事件等各方面情況，對試驗研究過程中的不良事件和嚴重不良事件進行跟蹤，保障受試者權(quán)益和中心利益；
4. 定期歸納并提交監(jiān)查報告，填寫相關(guān)報告及試驗記錄，確保數(shù)據(jù)真實準確、完整無誤；
5. 協(xié)調(diào)各研究中心、數(shù)據(jù)管理人員之間的溝通，培養(yǎng)并保持良好的關(guān)系；
6. 完成上級交辦的其它工作。
任職要求
1. 教育背景：藥學(xué)或醫(yī)學(xué)相關(guān)專業(yè)本科及以上學(xué)歷；
2. 工作經(jīng)驗：至少1年CRO行業(yè)或藥企CRA工作經(jīng)驗；
3. 專業(yè)技能：熟悉藥品注冊管理辦法、藥品臨床試驗及GCP等相關(guān)法規(guī)；
4. 語言能力：良好的英文讀寫能力；
5. 其他條件：有良好的人際關(guān)系和良好的溝通及語言表達能力。
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.
數(shù)據(jù)技術(shù)部
Data Technology Department
數(shù)據(jù)技術(shù)部總監(jiān) 1人
崗位職責(zé)
1. 負責(zé)部門組建及團隊的規(guī)劃與建設(shè)，并組織開展業(yè)務(wù)工作；
2. 負責(zé)中心網(wǎng)站、信息化辦公系統(tǒng)、醫(yī)研企協(xié)作平臺、臨床試驗數(shù)據(jù)管理平臺的建設(shè)與維護，確保臨床研究數(shù)據(jù)庫安全；
3. 監(jiān)督和管理臨床研究項目數(shù)據(jù)管理的相關(guān)活動，并對數(shù)據(jù)質(zhì)量負責(zé)；
4. 負責(zé)團隊內(nèi)的人員管理管理工作，對下級進行培養(yǎng)和考核；
5. 完成領(lǐng)導(dǎo)交辦的其他工作。
任職要求
1. 專業(yè)經(jīng)驗：10年或以上相關(guān)工作經(jīng)歷，有制藥企業(yè)或CRO公司團隊管理經(jīng)驗者優(yōu)先。
2. 教育背景：統(tǒng)計、信息/計算機等相關(guān)專業(yè)，碩士或以上學(xué)歷。
3. 政策法規(guī)：熟悉國內(nèi)國際藥械監(jiān)管的法律法規(guī)，及臨床試驗流程，熟悉臨床試驗數(shù)據(jù)管理相關(guān)國際標準；
4. 語言能力：具備在英語環(huán)境下勝任崗位職責(zé)的能力；
5. 特別優(yōu)秀者，可適當(dāng)放寬任職條件。
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.
數(shù)據(jù)工程師 若干人
崗位職責(zé)
1. 負責(zé)中心數(shù)據(jù)管理系統(tǒng)的日常維護和優(yōu)化，確保數(shù)據(jù)的準確性和安全性。
2. 參與數(shù)據(jù)采集、處理和分析流程的設(shè)計和實施，提高數(shù)據(jù)處理效率。
3. 與項目團隊協(xié)作，為臨床研究提供數(shù)據(jù)技術(shù)支持，確保數(shù)據(jù)的合規(guī)性和一致性。
4. 監(jiān)控數(shù)據(jù)管理系統(tǒng)的性能，及時發(fā)現(xiàn)并解決技術(shù)問題。
5. 參與制定和更新數(shù)據(jù)管理的標準操作流程 (SOPs)，協(xié)助進行數(shù)據(jù)管理系統(tǒng)的升級和新技術(shù)的集成。
6. 為內(nèi)部員工提供數(shù)據(jù)管理相關(guān)的培訓(xùn)和技術(shù)支持。
任職要求
1. 教育背景：計算機科學(xué)、信息技術(shù)或相關(guān)領(lǐng)域的本科及以上學(xué)歷；
2. 工作經(jīng)驗：至少2年的信息技術(shù)或數(shù)據(jù)技術(shù)工作經(jīng)驗；
3. 專業(yè)技能：熟悉數(shù)據(jù)庫管理，了解臨床研究數(shù)據(jù)管理的法規(guī)和指南；
4. 其他條件：具備良好的分析問題和解決問題的能力，能夠獨立工作；優(yōu)秀的溝通技巧，能夠與非技術(shù)人員有效溝通技術(shù)問題。
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.
政策法規(guī)辦公室
Regulatory Affairs Office
政策法規(guī)辦公室總監(jiān) 1人
崗位職責(zé)
1. 緊密跟蹤國內(nèi)外（中國、美國、歐洲等）藥事注冊相關(guān)法規(guī)和技術(shù)規(guī)范，及法規(guī)要求的最新動態(tài)；及時捕捉、解讀并反饋注冊相關(guān)政策的更新對于中心業(yè)務(wù)運營及戰(zhàn)略實施的影響，為中心決策提供建議，以確保中心的產(chǎn)品開發(fā)活動及相關(guān)研究的監(jiān)管合規(guī)性；
2. 為其他部門提供注冊法規(guī)指導(dǎo)及支持，指導(dǎo)中心項目研發(fā)合規(guī)開展；
3. 建立和優(yōu)化注冊法規(guī)事務(wù)相關(guān)內(nèi)部規(guī)章制度和工作流程，在項目研發(fā)、申報、審批過程中，與內(nèi)部各部門、外部檢測機構(gòu)、臨床機構(gòu)等各合作單位保持良好的溝通和管理工作，確保內(nèi)外部各部門各單位的工作符合注冊相關(guān)監(jiān)管法規(guī)的要求；
4. 建立與國內(nèi)外監(jiān)管和審評審批部門的良好關(guān)系，推動相關(guān)政策創(chuàng)新與落地；
5. 完成上級交辦的其它工作。
任職要求
1. 專業(yè)經(jīng)驗：10年以上藥品注冊申報工作經(jīng)歷，熟悉藥品研究開發(fā)全過程和藥品注冊相關(guān)法規(guī)，熟悉國際申報的流程與政策要求，有國際制藥公司注冊管理工作經(jīng)驗優(yōu)先；
2. 教育背景：臨床醫(yī)學(xué)、臨床藥學(xué)、藥事管理等相關(guān)專業(yè)碩士或以上學(xué)歷；
3. 語言能力：具備在英語環(huán)境下勝任崗位職責(zé)的能力；
4. 特別優(yōu)秀者，可適當(dāng)放寬任職條件。
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
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.
政策法規(guī)專員 若干人
崗位職責(zé)
1. 參與注冊項目的計劃、準備及執(zhí)行，確保項目成功注冊；
2. 編制注冊申請資料并準備其他法規(guī)文件，確保經(jīng)內(nèi)部審閱和批準之后的資料及時遞交；
3. 維護注冊文件的存檔；
4. 關(guān)注法規(guī)的變化，確保所提交的資料是符合法規(guī)要求的并且適用于不斷變化的法規(guī)。
任職要求
1. 教育背景：藥學(xué)或醫(yī)學(xué)相關(guān)專業(yè)碩士及以上學(xué)歷；
2. 工作經(jīng)驗：1-3年CRO或制藥公司工作經(jīng)驗，第三方實驗機構(gòu)或注冊工作經(jīng)驗優(yōu)先；
3. 專業(yè)技能：擅長文案工作，對相關(guān)注冊法規(guī)有一定的了解；
4. 語言能力：具有較好的中英文口語/書面溝通能力；
5.其他條件：熟練掌握計算機操作，熟練掌握Office辦公軟件。
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.
臨床項目經(jīng)理 2人
資格條件
1.在制藥企業(yè)或臨床CRO公司至少6年以上臨床運營、臨床監(jiān)察或相關(guān)工作經(jīng)驗，2年項目管理的工作經(jīng)驗；
2.醫(yī)學(xué)或藥學(xué)相關(guān)專業(yè)本科以上學(xué)歷；
3. 熟悉GCP與臨床研究的分期與要求；
4.有領(lǐng)導(dǎo)團隊的能力與親和力，有部門管理的執(zhí)行力，有跨部門協(xié)調(diào)與合作的能力。
5. 熟練使用計算機辦公軟件, 良好的英文讀寫能力。
崗位職責(zé)
1.負責(zé)單位各期臨床試驗的項目管理工作，對所負責(zé)的臨床研究項目進行全面的質(zhì)量控制 和進度管理，確保所有試驗嚴格按照GCP、SOP、試驗方案和中國法律、法規(guī)進行；
2.根據(jù)合同約定及臨床試驗方案要求，制定項目管理計劃，確定臨床試驗的職責(zé)范圍、團隊成員、進度計劃、財務(wù)預(yù)算等內(nèi)容，并在項目進行中不斷對項目管理計劃進行審核和 修改；
3.根據(jù)合同約定，定期匯報試驗進度，完成項目進展報告；
4.根據(jù)合同約定和項目計劃審核、批準項目組成員在實施項目過程中發(fā)生的實際工時和費 用，確保臨床試驗按照合同約定或與客戶商定的時限和預(yù)算內(nèi)完成各項工作；
5.對所負責(zé)的臨床試驗項目，督導(dǎo)項目組成員按時完成臨床試驗的全面啟動、執(zhí)行及結(jié)束工作；
6.在項目過程中識別、監(jiān)測并及時應(yīng)對各種風(fēng)險，正確評估相應(yīng)風(fēng)險對項目的整體影響并采取合理的改進措施。負責(zé)臨床試驗項目文檔的完整性、準確性、及時性；
7.作為臨床試驗項目的主要聯(lián)絡(luò)人，代表公司及項目團隊同申辦方、主要研究者及分包商 保持及時有效的溝通，確保項目相關(guān)重要信息被準確完整的傳遞，培養(yǎng)并保持與中心及 客戶的良好關(guān)系；
8.及時處理項目中的應(yīng)急突發(fā)事件，為項目組成員提供培訓(xùn)；
9.及時與其他部門人員就所負責(zé)的研究項目進行溝通和協(xié)調(diào)，如商務(wù)發(fā)展、財務(wù)、行政、醫(yī)寫作、數(shù)據(jù)與統(tǒng)計質(zhì)量保證人員等等。
10.協(xié)助商務(wù)部門尋求新項目合作及業(yè)務(wù)客戶拓展，提供臨床試驗相關(guān)信息，審核報價及相關(guān)合同文件，參加競標會；
11.根據(jù)合同約定及必要時對所負責(zé)的臨床試驗進行研究中心的協(xié)同訪視，并完成協(xié)同訪視報告；
12.支持并完成單位指派的其他臨床相關(guān)工作。
臨床注冊經(jīng)理 1人
資格條件
1. 本科及以上學(xué)歷，有二類、三類產(chǎn)品國內(nèi)、海外注冊5年以上經(jīng)驗。
2. 專業(yè)背景：臨床醫(yī)學(xué)、藥學(xué)、生物醫(yī)學(xué)工程等；
3. 有過一些基礎(chǔ)的品質(zhì)和體系經(jīng)驗，有超過5年以上的國內(nèi)、國際法規(guī)注冊經(jīng)驗；
4. 熟悉并掌握海外醫(yī)療器械管理及注冊等相關(guān)法規(guī)及技術(shù)指導(dǎo)原則；
5. 熟悉注冊申報中的各個環(huán)節(jié)，具有良好的申報資料英文撰寫能力和對申報資料審核的能力；
6. 條理清晰、邏輯思維縝密、性格溫和，具有良好的溝通協(xié)調(diào)能力，團隊協(xié)作能力。
崗位職責(zé)
1. 按照新藥、器械注冊法規(guī)和申報要求，負責(zé)申報材料撰寫、申報、復(fù)核、修改等報批工作，及時跟進審批進度，做好溝通和協(xié)調(diào)；
2.負責(zé)產(chǎn)品GMP中試生產(chǎn)工藝的建立及優(yōu)化，協(xié)助開展臨床試驗；
3.負責(zé)產(chǎn)品注冊過程中與內(nèi)外有關(guān)部門協(xié)調(diào)和溝通，協(xié)助建立和維護相關(guān)的事務(wù)關(guān)系；
4.隨時跟進和更新最新的法規(guī)、產(chǎn)業(yè)政策和行業(yè)指導(dǎo)意見等，挖掘申報信息，整理反饋給部門負責(zé)人；
5.帶領(lǐng)團隊統(tǒng)籌產(chǎn)品海外市場準入工作（美國FDA、歐盟CE-MDR、東南亞等）的策劃、組織和實施，制定產(chǎn)品注冊策略，協(xié)同研發(fā)編制產(chǎn)品技術(shù)要求等相關(guān)檢測/注冊技術(shù)文件；
6.負責(zé)與海外監(jiān)管部門對接，統(tǒng)籌處理各類事宜，積極完成相關(guān)監(jiān)管任務(wù)；
7.負責(zé)跟蹤海外國家法規(guī)和標準變化趨勢；
8.負責(zé)單位內(nèi)部法規(guī)意識的建立，并根據(jù)需要舉行法規(guī)知識培訓(xùn)；
9.協(xié)助建立體系和相關(guān)審核認證工作，協(xié)助各部門處理法規(guī)問題。
3 JOB APPLICATION
如果您對以上發(fā)布的職位感興趣，請發(fā)送個人中文或英文簡歷(PDF)至recruitment@smart.org.cn, 郵件主題為“崗位名稱-姓名-專業(yè)-高校人才網(wǎng)” 【快捷投遞：點擊下方“立即投遞/投遞簡歷”，即刻進行職位報名】；或登陸https://smart.org.cn/recruit/administrative-support/index.html搜索崗位直接投遞。
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.
