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position Name:    Clinical Ombudsman CRA
work place:    Shanghai
Wages:    25K-35Krelease date:    2020-11-30
Number of people required:    2Validity period:
Specific requirements:

   1. Responsible for the screening of research centers, pre-launch visits, and timely submission of relevant questionnaires and reports;

   2. Assist the convening of the researcher's meeting, as the main contact person of the research center personnel, responsible for the schedule of the relevant personnel;

   3. Assist researchers in submitting ethical review materials, responding to ethical review comments, and reviewing the integrity and compliance of ethical approval documents and member lists.

   norm;

   4. Responsible for the communication and revision of the research center contract;

   5. In accordance with the company's project plan, SOP and relevant laws and regulations, organize the start-up, supervision, and management of research centers.

   management, closing and other work, and timely complete the relevant visit report or project progress report;

   6. Responsible for organizing and coordinating the research center's audit from the applicant (or any third party) and official on-site inspection;

   7. Formulate the enrolment plan and process plan of the research center in charge, and customize relevant auxiliary tools according to the specific requirements of the research center;

   8. Manage the research center related materials (such as ICF, laboratory test kits) to ensure that the materials are sufficient and available;

   9. Manage research products, ensure that research products are used correctly, and ensure that research products are received, stored, handled, used, and recycled in compliance with requirements

   and record it truthfully, completely and accurately;

   10. Manage the recovery and destruction of research products and keep accurate records;

   11. Assist researchers to complete data entry in a timely manner and perform data cleaning in a timely manner;

   12. Ensure that the data collected by the research center is true, complete and accurate through data traceability and original document review;

   13. Ensure that investigators are able to process, record and report all AE/SAE/PSUR as required by regulations, and report relevant regulatory

   management department;

   14. Manage relevant documents and data, and enter relevant documents and data management systems (such as CTMS, PV, eTMF) in a timely manner as required by the company

   15. Make sure to participate in regular or irregular project management meetings, and be able to follow up on relevant resolutions in a timely manner;

   16. Ensure that you participate in regular or irregular training organized by the company, and ensure that any online training can be completed in a timely manner;

   17. Responsible for the calculation and submission of budgets for research center payments, and track related bills;

   Qualifications:

   1. Result-oriented, strong sense of responsibility, good communication skills, able to travel;

   2. 1 year or more experience in clinical trial monitoring

   3. Bachelor degree or above in clinical, pharmacy and other medicine-related majors;

   4. Proficient in operating Microsoft Office office software;

This position requires frequent travel.


position Name:    Research Director
work place:    Shanghai
Wages:    15K-18Krelease date:    2020-11-30
Number of people required:    1Validity period:
Specific requirements:

Responsibilities:

1. Conduct and conduct research and development experiments on the necessary team formation and R&D experiments for the scientific and technological projects determined by the company;

2. Responsible for or participate in the development of one or more research projects, product trial production test, sample analysis test and approval test;

3. Develop experimental plans, complete experimental records and experimental reports clearly and accurately, and organize, analyze and report data

4. Responsible for the writing and review of relevant SOPs, research protocols and reports, and experimental records;

5. Drafting process validation, process validation, comparability studies and other programs, and supporting the implementation of related work;

7. Support product-related IND and BLA applications, draft and review application documents, and promote clinical application of immunotherapy


job requirements:

1. Major in bioengineering/cell biology/molecular biology/tissue engineering, familiar with animal experiments is preferred;

2. Experience in immune cell culture and anti-tumor research is preferred;

3. Have more than 2 years of research and development experience in medical devices or pharmaceutical companies, and be able to write IND application materials;

4. Have a sense of teamwork, strong adaptability, love scientific research work, and have an innovative spirit.


position Name:    drug registrar
work place:    Shanghai
Wages:    10K-15Krelease date:    2020-11-30
Number of people required:    1Validity period:
Specific requirements:

Responsibilities:

1. Responsible for formulating product application plans, organizing and coordinating the writing and revision of drug application and registration documents, tracking the progress of drug registration, on-site audits, obtaining drug registration information in a timely manner, communicating and coordinating with relevant departments, and promoting the company's products to pass the approval of the national drug regulatory department ;

2. Have a comprehensive understanding of the development and application process and registration regulations of APIs and preparations, be able to independently handle or solve relevant problems in the process of drug application and registration, and have the ability to review application materials;

3. Responsible for the retrieval and translation of related drugs and literature;

4. Participate in the determination of the company's research and development projects and the provision of product information, put forward reasonable suggestions from the perspective of registration, and assist in clinical work related to registration;

Job conditions:

1. Bachelor degree or above in medicine or pharmacy;

2. More than three years of drug registration experience and management experience in registration-related departments in large and medium-sized pharmaceutical companies, and those with imported drug registration experience are preferred;

3. Familiar with the relevant laws and regulations of API and preparation registration and relevant drug research guidelines, have the ability to organize and review application materials, and be able to manage and conduct registration of multiple drug projects at the same time;

4. Familiar with the drug registration application procedures and the requirements for various drug registration application materials, have strong writing skills, and be able to independently complete the compilation, arrangement and declaration of technical data;

5. Good communication, coordination, and independent thinking and problem-solving skills;

6. Good written and oral communication skills in English;



position Name:    clinical medical manager
work place:    Shanghai
Wages:    15-25Krelease date:    2020-11-30
Number of people required:    1Validity period:
Specific requirements:

Job Responsibilities:

1. According to the company's requirements, formulate an academic promotion plan, organize academic promotion work or assist pharmaceutical representatives to implement the company's academic promotion activities;

2. Be familiar with product knowledge and conduct product training for customers, distributors, business personnel and other relevant personnel;

3. Accurately transmit the key information to promote the product, and expand the understanding and application of the company's products to customers;

4. Responsible for the improvement of academic promotion materials: collect and compile product academic materials, product promotion materials and training materials;

5. Production, collection and filing of clinical data of products.


Qualifications:

1. Master degree or above in medicine or pharmacy;

2. More than 2 years of work experience in pharmaceutical product promotion related positions is preferred;

3. Good communication, expression and presentation skills, and good teamwork spirit;

4. Be honest and upright, dedicated, outgoing personality, strong affinity.

, adapt to frequent business trips, good execution.


position Name:    clinical coordinator
work place:    Shanghai
Wages:    Negotiablerelease date:    2015-10-22
Number of people required:    2Validity period:
Specific requirements:

Job Function  Clinical Coordinator Clinical Fellow

Job Description :

Responsibilities:

1. Write clinical trial plans and single disease clinical research plans;

2. Drafting registration application materials; translation of clinical trial documents;

3. Carry out comprehensive supervision and liaison management of the research center, and complete the start, execution and termination of clinical trials in the center on time;
4. 
Responsible for the coordination, supervision and quality control of clinical trial hospitals, progress supervision, reporting, Document management, etc.;
5. 
Check and report the progress and quality of the trial, fill in the case report form, adverse reactions and other aspects, find problems, analyze problems, propose solutions and implement them;
6. 
Regularly summarize and submit monitoring reports; fill in relevant Reports and test records to ensure that the data is true, accurate and complete;
7. 
Communicate with clinicians and jointly negotiate to solve problems that arise, and coordinate the relationship between the research project leader, clinicians, auxiliary departments and other parties;

8. Complete other tasks assigned by the leader.

Job requirements:
1. 
Bachelor degree or above in medicine, pharmacy or life sciences;
2. More 
than year of clinical supervisor or related work experience in pharmaceutical companies or CRO companies; 3. At least or years of clinical research experience, participated in one The supervision of the above registered clinical trials; 4. Experience in clinical research of oncology drugs and products is preferred 5. Familiar with ICH guidelines, GCP and other relevant regulations; 6. Familiar with the whole process of drug development clinical trials 7. Good personal communication skills; 8. Good English, proficient in using computer office software.