JION US

1. According to the company's project plan, SOP and relevant laws and regulations, organize and carry out the site start-up, monitoring, site   management and site close-out, and timely complete the relevant visit report or project progress report;

2. Manage research products, ensure the correct use of research products, ensure that the receiving, storing, processing, using and recycling process of research products compliance with the requirements, and record them truthfully, completely and accurately;

3. Manage relevant documents and data, and timely supplement relevant documents and data management system (such as CTMS, PV, ETMF) as required by the company;

4. Ensure to participate in the regular or irregular training organized by the company, and ensure that any online training can be completed in time;

5. Responsible for the payment calculation and budget submission of the research center, and follow up the related bills.

1. Full time college degree or above;

2. Familiar with all kinds of office software, especially excel;

3. More than 1 year working experience in CRA;

4. Solid personality, work enthusiasm and strong sense of responsibility, with good communication and execution.

1. Assist in the whole process of clinical trial according to GCP, project requirements and SOP of the company.

2. Assist in the preparation and submission of clinical trial project documents; Responsible for the daily management of project documents, maintain and update the folder, ensure the accuracy, integrity and timely recovery of documents.

3. Assist in the management of materials, drugs and suppliers in clinical trials.

4. Organize and support project meeting, investigator meeting, etc., record meeting minutes, and assist to update project tracking form regularly.

5. Support contract and cost management in clinical trial project.

6. Support the project team to deal with the project affairs and communicatation .

1. Bachelor degree or above in clinical medicine, pharmacy or nursing;

2. Have a down-to-earth, dedicated work attitude, good interpersonal skills, good communication and coordination skills;

3. Familiar with common office software, including word, Excel, PowerPoint, etc;

4. Strong ability to work independently and team spirit.

1、 Responsible for formulating clinical project plan and controlling the overall progress of the project to ensure that the clinical research process compliance with GCP and protocol;

2、 Responsible for communication and coordination with the clinical research center, review and modify relevant documents and reports, organize and coordinate project audition and official inspection, etc;

3、 Responsible for communication and coordination with the sponsor, and provide regular / irregular reports according to the project requirements;

4、 Be responsible for the audit of other relevant data, plans, reports, etc;

5、 Responsible for daily management, training and work arrangement of team members;

6、 Complete other tasks assigned by leaders.

1. Bachelor degree or above in clinical, pharmaceutical or other medicine related majors;

2. At least 5 years clinical trial experience, at least 1 year project management experience;

3. Familiar with GCP, ICH-GCP, the Declaration of Helsinki and other relevant regulations and guidelines;

4. Goal oriented, strong sense of responsibility, good communication and coordination ability;

5. Be able to travel frequently;

6. Good at English, independent retrieving literature，especially in reading and writing.

1. The line manager of CRA and SCRA;

2. Responsible for the establishment, management and maintenance of a cohesive and competitive, positive CRA team;

3.According to the requirements of clinical trials, assign reasonably for work and resource that responsible by CRA and SCRA;

 4. Provide necessary support for CRA and SCRA's work and life;

5.Guiding and training for CRA and SCRA responsible for relevant working, and evaluate their performance;

6.Complete the performance evaluation of CRA and SCRA.

1. Working experience: more than 4 years of CRA experience and more than 1 year of project management / personnel management experience in MNC enterprise or large CRO company.

2. Capability requirements:

(1) Strong executive ability and rich management experience; Have the willingness to lead people;

(2) Excellent personnel management and communication skills, flexible mind ability;

(3) Have clear written and oral expression ability, good at active and positive communication, good at motivating the team;

(4) Strong adaptability.

3. Requirements of working skill:

(1) Rich knowledge and management experience in pharmaceutical industry;

(2) Familiar with ICH-GCP and the whole process of drug research and development, proficient in the whole process of clinical trials, familiar with the development and status of clinical research at domestic and international;

(3) Master the knowledge of clinical trial management standard, and be able to carry out relevant training and quality control;

(4) Skills with training and making the presentation in investigator meeting.

1. Responsible for data management team building, personnel training, task management and performance appraisal;

2. Responsible for the establishment and maintenance of data management related SOP, as well as the update of relevant management process documents;

3. Audit data management plan, data verification plan and procedure;

4. Data management and quality supervision;

5. Review data audit report and data management report;

6. Coordinate the project progress of the Department and track the progress.

1. At least 5 years working experience in data management, team management experience is required;

2. Bachelor degree or above in medicine, pharmacy, medical information management, biology, public health, natural science, medical statistics, or related majors, with good English level;

3. Familiar with relevant regulations, standards and guidelines (drug administration law, new drug approval method, ICH-GCP, CDISC, ICH MedDRA, etc.);

4. Careful, patient, strong sense of responsibility and team spirit;

5. Good communication and team management skills;

6. Good overall planning ability, organization and planning ability, able to reasonably arrange the work priorities and personnel allocation under multi project and multi time limit, so as to complete the work within the required time limit;

7. Strong learning ability and adaptability.

1. Under the leadership of the data management manager, complete the data management work of the project with quality and quantity guaranteed. Including but not limited to, writing DMP, participating in CRF design and database testing, training CRC or directly performing clinical trial data entry, performing data verification, modification, tracking and data query table management, writing data management report, etc;

2. Responsible for the cross verify of database quality among different projects;

3. Participate in the drafting and maintenance of data management related standard documents;

4. Establish and maintain good cooperation with colleagues in other business sectors;

5. 100% complete annual training courses arranged by departments and companies, and encourage lecturers to share experience and knowledge.

6. Complete other tasks assigned by line leader.

1. Bachelor degree or above in medicine, pharmacy, medical information management, biology, public health, natural science, medical statistics, or related majors. Knowledge and experience in programming and database is preferred;

2. Good command of English;

3. Careful, patient and responsible;

4. Good communication and teamwork skills, willing to continue learning.

1. Write programs to generate data sets (CDISC SDTM / Adam and other derived data sets);

2. Write programs to generate statistical tables, charts and lists;

3. Develop statistical verification procedures for data verification;

4. Assist in writing programming documents, including plans and instructions;

5. Assist in the development, implementation and validation of new technologies, macros and applications;

6. Assist project team leader to fulfill project responsibilities.

1. Basic statistical knowledge or drug clinical research related knowledge, 0-3 years working experience in clinical trial statistical programming;

2. Basic knowledge of SAS programming, such as base SAS, SAS macro language and SAS / STAT;

3. English at CET-4 level or above, professional literature reading barrier free;

4. Major is not limited, statistics, computer, mathematics major is preferred, with SAS base or above level certificate is preferred;

5. Careful, patient, good communication and teamwork skills, willing to continue learning.

1. Participate in guiding SAS programmer's programming related work, and review the output from SAS programmer;

2. Assist the superior to make the SAS macro program development plan, and participate in the writing and improvement of SAS macro program;

3. Write SAS program, establish statistical data list, statistical tables, and generate statistical reports;

4. Write SAS program for data processing, complete the data set preparation on time and with high quality;

5. Guide SAS programmers to provide programming support for data administrators and complete the statistical verification of data;

6. QC of the company's outsourcing projects, provide programming training for SAS programmers, and keep up with the latest development of statistical programming in the industry.

1. Bachelor degree or above in computer, mathematics, statistics, medicine or other related majors;

2. At least 5 years of SAS programming experience, with more than 1 year of experience;

3. Have SAS experience in pharmaceutical company or CRO company, and be familiar with the generation of SDTM and Adam datasets;

4. Familiar with domestic and international laws and regulations related to clinical trials and statistical programming, proficient in SAS language, python, R and other programming languages;

5. Familiar with and able to implement CDISC standard, able to complete the programming of various common statistical analysis models;

6. GCP training certificate is preferred;

7. Strong executive ability, oral and written ability, strong sense of responsibility, team spirit, willing to continue learning.

1. Familiar with CDE / FDA and other statistical requirements for clinical trial design, responsible for clinical trial protocol design;

2. Responsible for the blind and randomized design of clinical trials;

3. Responsible for writing SAP, Table Shell, SAR and other documents in the project;

4. Guide CRF design of project, perform DVP audit, TFL audit and other statistical tasks;

5. Participate in the establishment and maintenance of Biostatistics related standard documents, such as SOP, working document template, etc;

6. For the biostatistician who takes on the responsibility of leading people, it is necessary to do a good job in team cohesion management, cooperate with the Department Director and each project team to coordinate the allocation of human resources;

7. Participate in department training;

8. Complete other tasks assigned by line leader.

1. Master degree or above in medical statistics, health statistics, biostatistics, etc;

2. More than 3 years working experience in biostatistics project, working experience in large foreign pharmaceutical enterprises is preferred;

3. Have basic knowledge of Biostatistics and rich practical experience;

4. Familiar with the requirements of clinical research, but not limited to GCP, SOP and igh GCP;

5. Familiar with various trial design methods, proficient in clinical trial I-IV design and related workflow;

6. Good ability of data analysis, familiar with R or SAS statistical software;

7. Have the ability of organization, coordination, management, communication and teamwork.

1. Participate in the creation and validation of clinical trial database;

2. Participate in the programming and verification of logic verification rules;

3. Participate in the writing of clinical research project test plan, UAT document and test report;

4. Participate in clinical trial database management, such as account setting, account management and database locking;

5. Assist senior database designer to design project database;

6. To provide technical support and maintenance of project database for clinical projects.

1. Bachelor degree or above in computer, information technology, mathematics or other related majors;

2. Good understanding of database and good learning ability;

3. Good communication and cooperation skills;

4. Having the EDC experience is preferred.

1. Responsible for writing all kinds of clinical research documents, including but not limited to: clinical research protocol, clinical research report, IB, informed consent, etc;

2. Participate in the establishment and update of SOP for writing related medical documents; Responsible for the establishment, development and maintenance of writing templates for clinical research protocols, clinical research reports and other related medical documents; Participate in the establishment, update and maintenance of various writing tool forms within the Department;

3. Cooperate with relevant functional departments, actively participate in clinical research meetings, understand and correctly express clinical research results, and complete medical documents on time according to relevant national regulations, ICH-GCP, SOP and strategic development requirements of the company;

4. To control the quality of all kinds of medical documents in the same department according to relevant SOP requirements;

5. Write medical articles according to the results of clinical trials and literatures;

6. Provide medical training for relevant departments of clinical trial, and write professional articles for official account.

1. Master degree or above in medicine, pharmacy or biology; Clinical medicine is preferred;

2. At least 3 years related working experience;

3. Foreign language, computer application, clinical independent research ability, organization and coordination ability;

4. Dedicated, diligent and careful.

1. Develop clinical protocol, complete all requirements and details of the clinical trial protocol, and release a protocol that can be recognized and followed by all parties. Coordinate the concerns of the sponsor, investigators, monitors, study nurse and biological sample testing unit, and comprehensively consider the budget, cycle, success rate, operability and safety risk.

2. Skillfully organize and write the data of clinical trials related to CDE communication meeting, participate in face-to-face meeting, and communicate with CDE experts when necessary;

3. Establish good communication relationship with medical experts in key fields, and closely exchange research projects;

4. Work closely with CO, RA, BD, PV and other departments to provide advice, support and help according to project needs (select main investigator / participate in project meetings and agreement discussions).

5. Give medical professional guidance to the lower level.

1. Master degree or above in medicine, pharmacy or biology; Clinical medicine is preferred;

2. At least 3 years related working experience;

3. Foreign language, computer application, clinical independent research ability, organization and coordination ability;

4. Dedicated, diligent and careful.

1. Draft and complete the medical monitoring plan (MMP) according to the clinical trial protocol and the service content agreed in the contract. Update MMP if necessary.

2. Medical monitoring data list from eCRF: including inclusion / exclusion criteria, adverse events / serious adverse events, medical history, concomitant medication, laboratory examination, etc., and regularly submit a medical audit summary report to the project manager or the sponsor;

3. Review the bias and consistency of the protocol to ensure the medical compliance of the protocol;

4. Audit the medical coding according to MedDRA and who-drug requirements;

5. Review clinical research reports;

6. Cooperate with other departments within the company and provide medical support;

7. External communication with the sponsor or investigator.

1. Master degree or above in medicine, pharmacy or biology; Clinical medicine is preferred;

2.  At least 3 years related working experience;

3.  Foreign language, computer application, clinical independent research ability, organization and coordination ability;

4. Dedicated, diligent and careful.

1. Handle and report individual safety reports according to pharmacovigilance regulations, guidelines and company SOP, and ensure the timeliness of reports;

2. Familiar with PV database system, responsible for drug safety database building, data entry, etc.

3. Responsible for writing the safety management plan in the project;

4. Be responsible for the training of pharmacovigilance in the project;

5. Responsible for tracking and retrieving drug safety information;

6. Participate in the review / audit of regulators and sponsors;

7. Participate in the establishment and improvement of the company's pharmacovigilance related system and process;

8. Participate in the writing of pharmacovigilance related reports and report them within the specified time limit;

9. Assist relevant departments and pharmacovigilance team to complete relevant tasks.

1. Bachelor degree or above, major in medicine is preferred;

2. More than 4 years of PV related experience;

3. Have the ability of organizing, coordinating and solving problems;

4. Good communication skills and team management skills are preferred;

5. Global experience is preferred.

1. Evaluate the project from the perspective of registration, including the feasibility of registration, timeline, risk, research to be supplemented, etc.

2. Strategy formulation, considering the requirements of national policies and regulations, formulate a feasible registration strategy, and jointly determine the product development strategy with the market, clinical, R & D, etc;

3. Making plan, according to the requirements of national laws and regulations, including declaration content, format, time and other requirements, work together with the project team to develop the product development plan.

4. R & D follow-up: participate in project development, communicate closely with project team, ensure R & D meet registration requirements, answer registration related questions in R & D process, and assist in solving technical / professional questions. Ensure that new official regulations and requirements fall into the project.

5. Data preparation according to the overall plan of the project, make a specific data schedule, and do the corresponding overall time control and audit. According to the national requirements, the registration data templates of different projects are formulated, and the registration data written by various R & D departments are reviewed from the aspects of integrity, consistency and logicality. Ensure that the information meets the requirements of registration and declaration;

6. Registration declaration, review and approval follow-up apply for meeting according to national requirements, coordinate meeting preparation; Declare the information, pay close attention to the official feedback, and strive to obtain the review opinions in advance, so as to prepare the project team in advance. Including but not limited to data supplement, review and supplement before acceptance, organizing project team to answer and supplement;

7. Assist department head in team building and establish process assets of department organization. Comprehensive analysis and evaluation of unclear laws and regulations, forward-looking prediction, and formation of their own opinions.

1. Bachelor degree or above in medicine related major, at least 5 years’ experience in drug registration.

2. Familiar with drug registration regulations and guidelines.

3. Be able to handle and solve the problems in the process of drug registration independently.

4. Have the experience of sorting and writing declaration materials.

5. Maintain adequate product knowledge to ensure timely and professional response to company product inquiries during the registration process.

6. Strong literature retrieval ability.

7. Good English reading, writing and speaking skills, strong communication and coordination skills.

1. The image QC specialist carries out quality assurance inspection on the image according to the plan.

2. Medical image quality inquiry.

3. Use specific film reading software to complete the corresponding image basic processing (such as image format conversion, etc.).

4. Operate according to GCP, SOP and agreement.

5. Assist related internal and external staff to work.

6. Perform other duties required by the post.

1. Education background in medical imaging, medical imaging technology, Medical Bioengineering, pharmacy or biology, college degree or above.

2. At least 2 years working experience in medical imaging and clinical trials.

3. Familiar with medical imaging (such as CT, Mr, nuclear medicine, etc.), basic knowledge of clinical trials, GCP and other regulations.

4. Familiar with Microsoft office software.

1. Daily maintenance of SOP, ISO certification and other paper and electronic documents, and regular filing.

2. Preparation for ISO certification.

3. Assist in internal audit, audit and other work.

4. Assist in the construction and maintenance of quality system.

5. Assist in the related work of supplier audit.

6. Coordinate QA department training and other work.

1. Familiar with office and other office software.

2. Steady personality, careful work, sense of responsibility, result oriented.

3. Understand the analysis of quality tools and be familiar with ISO quality management system.

4. At least 1 year experience in CRO industry.

5. College or above in biology, medical examination, pharmacy and other related majors.

1. Make business plan, excavate business information, and be responsible for the implementation of the plan.

2. Responsible for the development of potential customers and maintenance of existing customers.

3. Responsible for the organization of project bidding and preparation of relevant materials.

4. According to customer requirements, coordinate quotation and contract, be responsible for business negotiation, and promote the successful signing of the project.

5. Follow up projects and manage contracts in execution.

6. Organize, coordinate and participate in various exhibitions and internal meetings.

7. Participate in the design of company publicity materials, use a variety of ways to establish the company's brand.

8. Assist the Department Manager to carry out the work and guide the daily work of the marketing specialist.

1. Bachelor degree or above, major in medicine, pharmacy and marketing.

2. More than 3 years working experience in pharmaceutical industry; Equivalent position experience in CRO industry is preferred.

3. Experience in business development and customer relationship network maintenance is preferred.

4. Clear written and oral expression ability, strong negotiation ability.

5. Strong management ability and cross department coordination ability.

6. Have working enthusiasm and sense of responsibility, good team spirit.

1. Participate in the business planning of the business development department and be responsible for the comprehensive affairs management of the business development department.

2. Establish and improve the business development related systems and processes, optimize the management system, improve efficiency through management.

3. Responsible for planning, coordinating and evaluating the company's annual performance indicators, reasonably planning and arranging quotation, bidding, order management, payment collection, etc.

4. Follow up the project operation progress and promote the delivery of service projects on time and with high quality.

5. Responsible for communication and coordination with business, clinical operation, finance and other departments.

6. Other work assigned by superior.

1. Highly identify with the culture and values of the company.

2. Strong self-driving force and working attitude to keep improving.

3. Bachelor degree or above, majored in medicine, pharmacy, biology, etc.

4. More than five years of business operation experience in pharmaceutical industry, with relevant experience in large biomedical enterprises and large CRO marketing department is preferred.

5. Strong ability of organization, coordination and communication, good control of project progress.

6. Have a certain management ability and good team spirit, with strong executive power.

1. Responsible for the method validation and detection of small molecular compound pharmacokinetics and other biological sample analysis projects.

2. Able to solve the problems in the process of using LC-MS / MS for quantitative analysis of biological samples independently.

3. Feedback the progress of the experiment in time to ensure that the experiment meets the requirements of GCP or GLP and departmental SOP.

4. Be able to complete analysis experiment, experiment record, report writing and document arrangement accurately and efficiently according to SOP.

5. Finish other work assigned by leader.

1. Master degree + 1 or bachelor degree + 2 years working experience in chemical analysis or pharmacy.

2. Working experience in LC-MS / MS is preferred.

3. Working experience in CRO or GLP laboratory is preferred.

4. Good organization and coordination, good team spirit and problem-solving ability.

5. Familiar with Microsoft Word, Excel and other office software. Good English reading and writing skills.

1. Responsible for the internal management and coordination of the team's small molecule bioanalysis project to ensure that all processes meet the requirements of regulations and departmental SOP.

2.  Ensure that the test personnel understand the clinical trial protocol and the protocol change, and evaluate and judge any deviation.

3.  Lead the team to complete LC-MS / MS method development, validation and sample detection of small molecule bioanalysis on time.

4.  Responsible for writing methodology validation protocol and sample analysis plan.

5.  Responsible for the foreign business exchange of small molecule bioanalysis.

6.  Responsible for the update of SOP files of the laboratory system, in line with the current regulatory requirements.

1.  Doctor degree, major in biology, analysis, pharmacy, etc., at least 2 years working experience in GLP bioanalysis, or at least 5 years of master's experience.

2.  Familiar with FDA, CFDA, EMA and other guidelines for biological analysis, NMPA or FDA GLP / GCP project verification experience is preferred.

3.  Experience in quantitative analysis of drugs by LC-MS / MS, and experience in micromolecular bioanalysis in domestic and foreign bioanalytical enterprises is preferred.

4.  More than 2 years project and team management experience are preferred.

5.  Have keen insight, excellent innovative spirit, organization and coordination ability and problem-solving ability.

6.  Be able to bear hardships and stand hard work, have a strong sense of responsibility, work actively, have good communication skills and teamwork ability.