1 INTRODUCTION
粵港澳大灣區(qū)國際臨床試驗(yàn)中心（以下簡(jiǎn)稱“中心”）是由深圳醫(yī)學(xué)科學(xué)院計(jì)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(yàn)公共服務(wù)平臺(tái)。
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(yàn)中心是貫徹落實(shí)《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(hào)）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(jìn)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(dú)特的區(qū)位優(yōu)勢(shì)和不斷疊加的政策優(yōu)勢(shì)，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(yàn)平臺(tái)，為國際國內(nèi)藥械研發(fā)機(jī)構(gòu)提供一流臨床試驗(yàn)技術(shù)支撐與運(yùn)營管理服務(wù)。同時(shí)，中心還將發(fā)揮臨床試驗(yàn)政策規(guī)則體系改革的“頭雁”作用，推進(jìn)臨床試驗(yàn)規(guī)則和標(biāo)準(zhǔn)與國際對(duì)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(jìng)爭(zhēng)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(jī)構(gòu)服務(wù)及行政辦公室、方案開發(fā)與方法學(xué)部、項(xiàng)目運(yùn)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(gè)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(jī)制、開展國際交流與合作等職能。現(xiàn)根據(jù)中心組建和運(yùn)行工作需要，深圳醫(yī)學(xué)科學(xué)院面向社會(huì)誠招臨床方案開發(fā)、臨床項(xiàng)目運(yùn)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.
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(biāo)，組建方案開發(fā)與方法學(xué)平臺(tái)，并組織開展業(yè)務(wù)工作；
2. 負(fù)責(zé)組織制定中心方案開發(fā)與生物統(tǒng)計(jì)業(yè)務(wù)工作制度、規(guī)章、操作標(biāo)準(zhǔn)等規(guī)范，并監(jiān)督實(shí)施；
3. 組織對(duì)部門人員進(jìn)行專業(yè)培訓(xùn)、指導(dǎo)與考核，參與部門人員招聘；
4. 負(fù)責(zé)組織部門開展與臨床試驗(yàn)項(xiàng)目方案開發(fā)、統(tǒng)計(jì)分析工作，并在計(jì)劃時(shí)間內(nèi)高質(zhì)量地完成；
5. 負(fù)責(zé)組織建立、維護(hù)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(jì)分析中遇到的專業(yè)問題與專家進(jìn)行溝通咨詢；
6. 負(fù)責(zé)就部門業(yè)務(wù)與中心其他相關(guān)部門進(jìn)行溝通和協(xié)調(diào)，組織部門對(duì)中心其他部門提供及時(shí)、高效的技術(shù)支持；
7. 完成上級(jí)交辦的其他工作。
任職要求
1. 專業(yè)經(jīng)驗(yàn)：具有在生物醫(yī)藥或CRO行業(yè)10年項(xiàng)目開發(fā)或方法學(xué)平臺(tái)工作經(jīng)驗(yàn)，3年部門管理的工作經(jīng)驗(yàn)，精通臨床試驗(yàn)設(shè)計(jì)；
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(jì)師 若干人
崗位職責(zé)
1. 負(fù)責(zé)制定臨床研究統(tǒng)計(jì)計(jì)劃，完成臨床試驗(yàn)方案中的統(tǒng)計(jì)部份設(shè)計(jì)，包括樣本量計(jì)算、隨機(jī)和編盲、統(tǒng)計(jì)分析計(jì)劃等；
2. 參與方案討論會(huì)，并提供統(tǒng)計(jì)支持；
3. 臨床數(shù)據(jù)統(tǒng)計(jì)分析與報(bào)告審核；
4. 臨床研究統(tǒng)計(jì)部分供應(yīng)商管理，審核或獨(dú)立撰寫統(tǒng)計(jì)分析計(jì)劃，可獨(dú)立進(jìn)行研究數(shù)據(jù)的資料處理和統(tǒng)計(jì)分析；
5. 能在工作中使用SAS等軟件進(jìn)行統(tǒng)計(jì)分析程序編寫，進(jìn)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(píng)討論。
任職要求
1. 教育背景：碩士及以上學(xué)歷，生物統(tǒng)計(jì)、醫(yī)學(xué)統(tǒng)計(jì)等相關(guān)專業(yè)；
2. 工作經(jīng)驗(yàn)：獨(dú)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(yàn)設(shè)計(jì)與統(tǒng)計(jì)分析流程，2年以上相關(guān)經(jīng)驗(yàn)；
3. 專業(yè)技能：熟悉國內(nèi)外臨床試驗(yàn)相關(guān)的生物統(tǒng)計(jì)學(xué)技術(shù)指導(dǎo)原則，熟練運(yùn)用臨床試驗(yàn)常規(guī)統(tǒng)計(jì)軟件；
4. 其他條件：有較強(qiáng)的邏輯性、強(qiáng)烈的團(tuán)隊(duì)合作意識(shí)與責(zé)任感，有較強(qiáng)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(xiàng)目運(yùn)營與質(zhì)量管理部
Project Operations and Quality Management Department
項(xiàng)目運(yùn)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(biāo)，組建項(xiàng)目運(yùn)營與質(zhì)量管理部門，并組織開展業(yè)務(wù)工作；
2. 負(fù)責(zé)組織制定中心臨床運(yùn)營、項(xiàng)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(shí)施各環(huán)節(jié)的工作制度、規(guī)章、操作標(biāo)準(zhǔn)等規(guī)范，并監(jiān)督實(shí)施；
3. 組織對(duì)部門人員進(jìn)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(jìn)行良性的互動(dòng)；與涉及的藥政法規(guī)監(jiān)管部門，醫(yī)學(xué)領(lǐng)域?qū)＜摇⒖蒲性核认嚓P(guān)部門，建立并保持交流和溝通的渠道；
5. 完成上級(jí)交辦的其他工作。
任職要求
1. 專業(yè)經(jīng)驗(yàn)：在制藥企業(yè)或臨床CRO公司至少10年臨床運(yùn)營、臨床監(jiān)察或相關(guān)工作經(jīng)驗(yàn)，3年部門管理的工作經(jīng)驗(yàn)，廣泛的醫(yī)院網(wǎng)絡(luò)資源，熟悉臨床試驗(yàn)運(yùn)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(yàn)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.
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(fù)責(zé)部門組建及團(tuán)隊(duì)的規(guī)劃與建設(shè)，并組織開展業(yè)務(wù)工作；
2. 負(fù)責(zé)中心網(wǎng)站、信息化辦公系統(tǒng)、醫(yī)研企協(xié)作平臺(tái)、臨床試驗(yàn)數(shù)據(jù)管理平臺(tái)的建設(shè)與維護(hù)，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(xiàng)目數(shù)據(jù)管理的相關(guān)活動(dòng)，并對(duì)數(shù)據(jù)質(zhì)量負(fù)責(zé)；
4. 負(fù)責(zé)團(tuán)隊(duì)內(nèi)的人員管理管理工作，對(duì)下級(jí)進(jìn)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(yàn)：10年或以上相關(guān)工作經(jīng)歷，有制藥企業(yè)或CRO公司團(tuán)隊(duì)管理經(jīng)驗(yàn)者優(yōu)先。
2. 教育背景：統(tǒng)計(jì)、信息/計(jì)算機(jī)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(yàn)流程，熟悉臨床試驗(yàn)數(shù)據(jù)管理相關(guān)國際標(biāo)準(zhǔn)；
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(fù)責(zé)中心數(shù)據(jù)管理系統(tǒng)的日常維護(hù)和優(yōu)化，確保數(shù)據(jù)的準(zhǔn)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(jì)和實(shí)施，提高數(shù)據(jù)處理效率。
3. 與項(xiàng)目團(tuán)隊(duì)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?cái)?shù)據(jù)管理系統(tǒng)的性能，及時(shí)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(biāo)準(zhǔn)操作流程 (SOPs)，協(xié)助進(jìn)行數(shù)據(jù)管理系統(tǒng)的升級(jí)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(jì)算機(jī)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(yàn)：至少2年的信息技術(shù)或數(shù)據(jù)技術(shù)工作經(jīng)驗(yàn)；
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(dú)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.
臨床項(xiàng)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(yùn)營、臨床監(jiān)察或相關(guān)工作經(jīng)驗(yàn)，2年項(xiàng)目管理的工作經(jīng)驗(yàn)；
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(tuán)隊(duì)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(jì)算機(jī)辦公軟件, 良好的英文讀寫能力。
崗位職責(zé)
1.負(fù)責(zé)單位各期臨床試驗(yàn)的項(xiàng)目管理工作，對(duì)所負(fù)責(zé)的臨床研究項(xiàng)目進(jìn)行全面的質(zhì)量控制 和進(jìn)度管理，確保所有試驗(yàn)嚴(yán)格按照GCP、SOP、試驗(yàn)方案和中國法律、法規(guī)進(jìn)行；
2.根據(jù)合同約定及臨床試驗(yàn)方案要求，制定項(xiàng)目管理計(jì)劃，確定臨床試驗(yàn)的職責(zé)范圍、團(tuán)隊(duì)成員、進(jìn)度計(jì)劃、財(cái)務(wù)預(yù)算等內(nèi)容，并在項(xiàng)目進(jìn)行中不斷對(duì)項(xiàng)目管理計(jì)劃進(jìn)行審核和 修改；
3.根據(jù)合同約定，定期匯報(bào)試驗(yàn)進(jìn)度，完成項(xiàng)目進(jìn)展報(bào)告；
4.根據(jù)合同約定和項(xiàng)目計(jì)劃審核、批準(zhǔn)項(xiàng)目組成員在實(shí)施項(xiàng)目過程中發(fā)生的實(shí)際工時(shí)和費(fèi) 用，確保臨床試驗(yàn)按照合同約定或與客戶商定的時(shí)限和預(yù)算內(nèi)完成各項(xiàng)工作；
5.對(duì)所負(fù)責(zé)的臨床試驗(yàn)項(xiàng)目，督導(dǎo)項(xiàng)目組成員按時(shí)完成臨床試驗(yàn)的全面啟動(dòng)、執(zhí)行及結(jié)束工作；
6.在項(xiàng)目過程中識(shí)別、監(jiān)測(cè)并及時(shí)應(yīng)對(duì)各種風(fēng)險(xiǎn)，正確評(píng)估相應(yīng)風(fēng)險(xiǎn)對(duì)項(xiàng)目的整體影響并采取合理的改進(jìn)措施。負(fù)責(zé)臨床試驗(yàn)項(xiàng)目文檔的完整性、準(zhǔn)確性、及時(shí)性；
7.作為臨床試驗(yàn)項(xiàng)目的主要聯(lián)絡(luò)人，代表公司及項(xiàng)目團(tuán)隊(duì)同申辦方、主要研究者及分包商 保持及時(shí)有效的溝通，確保項(xiàng)目相關(guān)重要信息被準(zhǔn)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(shí)處理項(xiàng)目中的應(yīng)急突發(fā)事件，為項(xiàng)目組成員提供培訓(xùn)；
9.及時(shí)與其他部門人員就所負(fù)責(zé)的研究項(xiàng)目進(jìn)行溝通和協(xié)調(diào)，如商務(wù)發(fā)展、財(cái)務(wù)、行政、醫(yī)寫作、數(shù)據(jù)與統(tǒng)計(jì)質(zhì)量保證人員等等。
10.協(xié)助商務(wù)部門尋求新項(xiàng)目合作及業(yè)務(wù)客戶拓展，提供臨床試驗(yàn)相關(guān)信息，審核報(bào)價(jià)及相關(guān)合同文件，參加競(jìng)標(biāo)會(huì)；
11.根據(jù)合同約定及必要時(shí)對(duì)所負(fù)責(zé)的臨床試驗(yàn)進(jìn)行研究中心的協(xié)同訪視，并完成協(xié)同訪視報(bào)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(cè)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(cè)5年以上經(jīng)驗(yàn)。
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(yàn)，有超過5年以上的國內(nèi)、國際法規(guī)注冊(cè)經(jīng)驗(yàn)；
4. 熟悉并掌握海外醫(yī)療器械管理及注冊(cè)等相關(guān)法規(guī)及技術(shù)指導(dǎo)原則；
5. 熟悉注冊(cè)申報(bào)中的各個(gè)環(huán)節(jié)，具有良好的申報(bào)資料英文撰寫能力和對(duì)申報(bào)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(tuán)隊(duì)協(xié)作能力。
崗位職責(zé)
1. 按照新藥、器械注冊(cè)法規(guī)和申報(bào)要求，負(fù)責(zé)申報(bào)材料撰寫、申報(bào)、復(fù)核、修改等報(bào)批工作，及時(shí)跟進(jìn)審批進(jìn)度，做好溝通和協(xié)調(diào)；
2.負(fù)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(yàn)；
3.負(fù)責(zé)產(chǎn)品注冊(cè)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(hù)相關(guān)的事務(wù)關(guān)系；
4.隨時(shí)跟進(jìn)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(bào)信息，整理反饋給部門負(fù)責(zé)人；
5.帶領(lǐng)團(tuán)隊(duì)統(tǒng)籌產(chǎn)品海外市場(chǎng)準(zhǔn)入工作（美國FDA、歐盟CE-MDR、東南亞等）的策劃、組織和實(shí)施，制定產(chǎn)品注冊(cè)策略，協(xié)同研發(fā)編制產(chǎn)品技術(shù)要求等相關(guān)檢測(cè)/注冊(cè)技術(shù)文件；
6.負(fù)責(zé)與海外監(jiān)管部門對(duì)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(fù)責(zé)跟蹤海外國家法規(guī)和標(biāo)準(zhǔn)變化趨勢(shì)；
8.負(fù)責(zé)單位內(nèi)部法規(guī)意識(shí)的建立，并根據(jù)需要舉行法規(guī)知識(shí)培訓(xùn)；
9.協(xié)助建立體系和相關(guān)審核認(rèn)證工作，協(xié)助各部門處理法規(guī)問題。
3 JOB APPLICATION
如果您對(duì)以上發(fā)布的職位感興趣，請(qǐng)發(fā)送個(gè)人中文或英文簡(jiǎn)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(diǎn)擊下方“立即投遞/投遞簡(jiǎn)歷”，即刻進(jìn)行職位報(bào)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.
