Submit your resume
Fantastic Bioimaging CO., LTD.
Contact：Ms. Sun
E-mail：rui.sun@tigermedgrp.com
Tell：+86-21-60830899
Insurance & Housing Fund
Annual Leave
Annual Salary Increment
Annual Health Checkup
Physical Activity
Promotion Opportunities
Flexible Work Schedule
Holiday Gift
Team Building
Afternoon Tea
1. Responsible for recruitment, compensation and welfare, maintenance of employee relations, organizing and developing work, and smoothing the work of human resources.
2. Handle the procedures of employees’ enrollment and departure, sign and renew labor contracts, maintain labor relations and deal with social security work.
3. Establish recruitment channels, screen resumes and complete interviews.
4. Manage staff ranks and salaries, implement performance appraisal and related work. Collect and analyze KPI scores.
5. Manage sick leave and personal leave, supervise and organize staff attendance. Establish, update and maintain archives, etc.
6. Conduct staff training, establish and implement of personnel management system.
1. Full-time bachelor degree or above (master degree preferred).
2. Familiar with basic concepts and terms of human resource management, business process, personnel policies, and laws and regulations. Familiar with the company's internal HR management process, common interview evaluation methods, and know-how to ask for help in dealing with common HR problems.
3. 3-5 year working experience in recruitment (Proficiency in English is preferred).
4. Good communication, expression and coordination skills, proficiency in Microsoft Office software is required.
5. Integrity and honesty, seeking truth from facts, professional cooperation, openness and inclusiveness.
1. Establish, modify, update and improve SOPs, and maintain, manage SOPs.
2. Take charge of audit work to ensure the quality system.
3. Implement staff training.
4. Assist to complete the related tasks assigned from various departments including but not limited to Business Development Department.
1. Bachelor degree or above related to medicine, pharmacy or biology, clinical trial experience is preferred.
2. Master drug development and clinical trial process, have a full knowledge of relevant regulations, such as GCPs, and obtain GCP certificate.
3. CET-4, and do well in Microsoft Office.
1. Work with internal clinical operation team to ensure meeting compliance standards;
2. Manage project quality according to GCP, communicate with people involved, and provide support for all project teams;
3. Identify and visit compliance risk areas. Develop and implement measures of risk mitigation.
4. Manage routine and non-routine GCP audit plan of quality assurance, including clinical research centers, suppliers, processes, systems and study documents to ensure the accuracy and completeness of study data, and to ensure quality compliance with internal processes, regulatory guidelines, relevant laws and regulations.
5. Review and approve clinical SOP.
6. Develop and implement clinical QA Policy/SOP.
7. Develop and implement detailed audit plan and annual GCP audit plan.
8. Ensure timely and effectively follow up all found or specified quality problems;
9. Do QA audit of GCP protocol, ICF, CSR and other clinical trial specific documents.
10. Guide or execute CSR audit and eTMF audit.
11. Prepare written audit reports, and communicate findings and recommendations. And evaluate the adequacy and completeness of corrective and preventive action plans.
12. Manage internal GCP, relevant compliance training, and relevant QC training of enterprise internal business.
13. Work closely with departments of clinical development, clinical operations, biometrics, PV/safety and other departments to ensure the prepared work of compliance.
14. Provide management reports on strategies, plans and complaint trends.
15. Support process improvement plan, and lead continuous process improvement related to quality.
16. Maintain necessary knowledge and procedures of applicable regulations, guidelines and standards.
17. Ensure ongoing inspection preparation and support the inspections requested by sponsors and regulatory agencies, as well as follow up management and completion of CAPA.
1. Education, certification, Experience • Bachelor's degree or advanced degree in a scientific discipline, quality assurance professional certification preferred;
2. Obtain extensive experience of GCP QA in the work environment and GCP audit, including on-site inspection for supplier and clinical trial site. Have a good command and experience of international ICH-GCP, clinical quality laws, regulations and guidelines.
3. At least 3-year working experience of quality assurance in pharmaceutical industry, and have experience in interacting with regulatory inspection and regulatory authorities.
4. Have experience with FDA or other regulatory inspection agencies, sponsors or CROs. And have strong leadership, ability to organize and interact with senior leaders at different levels.
5. Have deep understanding of GCP and ICH clinical requirements. Have excellent written/oral communication skills and interpersonal skills to establish key networks and business relationships at all levels of the business.
6. Fluent in written and spoken English, able to conduct foreign language inspection.
7. Detail-oriented, capable of detecting and correcting various types of errors/inconsistencies.
8. Do well in Microsoft Office and Adobe Acrobat.
9. Experience with QMS, EDC, IRT, eTMF, EMR system is preferred.
1. Conduct image quality control and provide professional image support in accordance with specific research guidelines.
2. Work with project manager to support sponsors’ image requirement.
3. Communicate with sponsors, sites, CROs and other project suppliers, including domestic and international travels, to ensure high-quality image data and deliveries.
4. Be the supervisor of independent image analysis.
5. Support projects.
6. Update and maintain project text records as required, and follow up the projects;
7. Other tasks assigned by supervisor.
1. College degree or above in medical imaging, biomedical engineering, pharmacy or biology related education background.
2. Be familiar with basic knowledge of medical imaging (such as CT, MR, radionuclide, B-ultrasound, DSA, etc.) and clinical trial research, and understand SFDA, ICH regulations.
3. Proficient in Microsoft Office.
4. Other basic requirements: result-oriented and good cooperation spirit, clinical trial experience is preferred.
1. Assist project manager in drafting Imaging Manual, and archive project documents.
2. Reserve conference room, and takemeeting minutes.
3. Receive, distribute, importing image data and send reports.
4. Management of project materials.
5. Maintain a good cooperative relationship with sponsors ,sites,CRC and CRA.
6. Assist PM and IS withtheirwork.
7. Organize project documentation project documents.
1. Medical imaging, biomedical engineering, pharmacy, biology and other related-major , full-time undergraduate degree or above.
2. Proficient in office software.
3. Good communication skills and strong teamwork spirit.
4. Clear logical thinking and serious working attitude.
5. Obey the arrangement and management.
1. Formulate project management plans and project reports in accordance with FAB’s SOPs, ICH-GCP, schemes and image quality requirements.
2. Complete producing timelines, fund budgets and site management of research projects.
3. Develop specific imaging manual and operating procedure manual.
4. Assist to screen independent reviewers/radiologists.
5. Learn and master reading requirements and guidelines set by specific projects.
6. Monitor independent/third party reading and ensure reading quality.
7. Update and maintain project text records as required and follow up them.
8. Keep good cooperative relationship with sponsors, researchers and CRAs.
9. Provide project members with necessary training to establish high-efficiency clinical teams.
1. Bachelor degree or above in related education background such as medical imaging, biomedical engineering, pharmaceutical engineering or biology. Related working experience in CRO industry is preferred. Having basic knowledge of medical imaging (e.g. CT, MR radionuclide, B-ultrasound, DSA, etc.) and clinical trial research is preferred.
2. 4-6 year working experience in the hospital radiology department (such as radiologist or qualified radiologist, etc.) is preferable.
3. Proficiency in English and Chinese, and extensive usage of Microsoft Office.
4. Have good communication, presentation and negotiation skills, and be able to establish a good relationship with sponsors and sites.
1. Write and translate relevant materials related to clinical trials.
2. Cooperate with clinical operation team to prepare and submit relevant medical materials according to key time points of clinical trial projects.
3. Cooperate with project team to communicate with sponsors and research centers, and to provide professional replies and opinions.
4. Assist relevant departments to implement clinical trial initiation, budget control, preparation of spreadsheets and data quality management.
5. Do medical review of image data and protocol deviation (PD) in the process of clinical trials.
6. Provide medical support to CRA and research center, timely reply to medical questions, sort out and record them. And discuss research plans and professional issues with experts in related fields.
7. Do literature retrieval and interpretation, and provide in-house staff or sponsors with the latest disease information and product knowledge.
8. Strictly follow the internal SOPs and QA workflow, consciously establish good cooperative relationship with quality control, data management, statistics and other departments. Assist to develop inter-department cooperation workflow when necessary to constantly improve work efficiency.
9. Participate in other medical related work.
1. Master or doctor degree in medicine or related fields.
2. Do medical research, medical affairs or medical writing at least 3years in clinical medicine, imaging, and pharmaceutical industry or CROs, with the experience of clinical internship in hospitals, new drug development in CROs, medicine in pharmaceutical companies.
3. Have strong self-learning ability, good logical thinking and ability to work independently, and have good writing skills.
4. Have knowledge of ICH-GCP and Chinese medical policies and regulations.
5. Extensive usage of Microsoft Office and medical writing software, such as Adobe Acrobat, image processing software, Word, Excel, PowerPoint, literatures management software, GraphpadPrism, etc.
6. Good English reading, writing and translation skills.
7. Good analysis, planning and execution skills.
1. Retrieve medical information and literatures according to the project requirements of clinical trial.
2. Draft, write or review and modify relevant documents related to clinical trial images.
3. Write and translate other professional medical documents related to clinical trials.
1. Bachelor degree or above in medicine, pharmacy & pharmacology, experience in oncology is preferred;
2. Ability to search, translate and analyze medical literatures both in Chinese and English, and to write medical reports both in Chinese and English.
3. Familiar with clinical trial process, relevant experience is preferred.
4. Able to independently think, solve problems, and be good at communication.
1. Accomplish the set business development goals, and seek business opportunities at home and abroad.
2. Maintain good relationship with targeted customers to ensure the recognition of the company.
3. Negotiate with customers according to their requirements, to facilitate the signing of contracts.
4. Superviser needs to guide and facilitate the subordinate business development specialists.
5. Manager needs to assist company leaders in making annual business development plan and lead department to accomplish task targets.
1. Experience in business development.
2. Bachelor degree in clinical medicine, pharmacy, life science or marketing is preferred; working experience in pharmaceutical or medical device company is preferred; CRO related working experience is preferred.
3. Strong anti-stress ability, strong sense of responsibility and high work enthusiasm, good communication and negotiation skills. Accept frequent business trips.
4. CET-4.
Submit your resume
Fantastic Bioimaging CO., LTD.
Contact：Ms. Sun
E-mail：rui.sun@tigermedgrp.com
Tell：+86-21-60830899
Shanghai Office
Rm 208, Building 1, Universal Science & Technology Plaza, No. 958 Zhenbei Rd, Shanghai, China
Hanzhou Office
Rm 1802, Fl.18, Building 8, No. 19, Jugong Rd, Xixing Street, Binjiang District, Hangzhou, China
Jiaxing Office
Rm 406, Tigermed Building, No. 28 Huixin Rd, Daqiao Town, Nanhu District, Jiaxing, China
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