Professional：

Major in clinical medicine or pharmacy, with more than 8 years of relevant work experience in clinical research management in pharmaceutical companies

Job description:

1. Responsible for the development and management of clinical trial projects;

2. Responsible for the quality and compliance of clinical trial projects;

3. Coordinating various relevant departments internally; establishing and maintaining a good relationship with the research center and other partners externally.

Professional：

Clinical medicine, pharmacy, biology and other related majors, clinical medicine is preferred, with more than 8 years of clinical research management experience

Job description:

1. Lead the clinical team to formulate clinical plans and related documents, initiate and complete the entire clinical trial in an efficient and timely manner;

2. Responsible for evaluating and screening PI, CRO and clinical trial bases, leading the various processes of clinical research;

3. Ensure the quality and compliance of clinical trial projects;

4. Provide clinical trial recommendations for the company's product pipeline preclinical projects.

Professional：

Major in clinical medicine, pharmacology or biology, with more than 5 years of clinical research experience, and more than 3 years of clinical research project management experience in new anti-tumor drugs

Job description:

1. Responsible for the implementation of the company's new drug clinical trials, monitoring the clinical trial process, and ensuring compliance with GCP requirements;

2. Responsible for communicating and coordinating with clinical investigators, CRO and other partners to promote the progress of clinical projects;

3. Participate in the formulation of clinical research plans and research programs, and evaluate and screen cooperative units;

4. Participate in the writing of clinical related materials for project application, and assist registered personnel in completing the new drug application work.

Professional：

Medicine, pharmacy or biology, nursing and other related majors, familiar with ICH/GCP, Chinese GCP related regulations and requirements, more than 2 years of CRA experience is preferred

Job description:

1. Responsible for the selection of research units and main researchers, and the formulation of research budgets;

2. Responsible for selecting clinical trial institutions, preparing ethical data, signing clinical trial contracts, and organizing researcher conferences;

3. Follow up the progress of clinical trials and assist researchers to solve problems that may arise in the screening, enrollment and follow-up of subjects in a timely manner;

4. Responsible for monitoring the quality of the clinical research center, identifying and proposing solutions;

5. Track the progress of clinical research, coordinate the resources of the research center, complete the research progress in accordance with the trial progress plan; submit the supervision report in time.

Professional：

Clinical medicine, pharmacy or related majors, more than 3 years of supervisory work experience, more than 1 year of QA experience, familiar with relevant laws and regulations on drug clinical research

Job description:

1. Establish and improve the quality management system documents of the clinical medicine department, follow up relevant laws and regulations and related requirements, and timely compile and upgrade the clinical department SOP;

2. According to the progress status of the project, timely audit the relevant documents of the clinical medicine department;

3. Responsible for the quality control of clinical trial projects, audit clinical trials, and ensure that the entire clinical trial process is conducted in accordance with GCP, trial protocol, and SOP;

4. Regular evaluation, assessment and audit of third-party suppliers.

Professional：

Medicine, pharmacy, pharmacology, biopharmaceutical and other related majors, with more than 10 years of relevant work experience in pharmaceutical companies or CRO companies, including at least 5 years of registered manager position experience, overseas study or work background is preferred

Job description:

1. Responsible for formulating the company's new drug and pipeline product registration plan and implementation preparation;

2. Master the latest relevant laws and regulations, and maintain a global vision of the company's products and related therapeutic areas of competing products;

3. Analyze the compliance of the data, point out the data that is different from the legal requirements and request supplementary data to meet the legal requirements;

4. Establish a communication platform with regulatory authorities to provide professional consultations for R&D and clinical medical teams.

Professional：

Medicine, pharmacy, pharmacology, biopharmaceutical and other related majors, more than 3 years of relevant work experience in chemical drug clinical application and registration, familiar with the relevant laws and regulations and application process of drug application and filing (registration)

Job description:

1. Responsible for formulating product clinical registration project plan;

2. Compile and review the application materials for clinical registration of drugs, and complete the application in a timely manner in accordance with the project application progress and procedures;

3. Responsible for tracking the progress of drug registration, and cooperating with the drug regulatory authority to handle relevant procedures;

4. Responsible for communicating and coordinating clinical application and registration matters with relevant industry departments;

5. Establish good working contacts with relevant reporting and registration agencies.

Professional：

Statistics, mathematics, computer science, medicine and other related majors;

Participate in more than 10 projects and lead at least 5 of them;

Familiar with SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph and SAS/SQL, proficient in CDISC standards;

Familiar with relevant regulations, such as GCP, ICH, etc.

Job description:

1. Responsible for the implementation of clinical data management and statistical analysis programming;

2. Responsible for directing and executing the writing, reviewing, processing of SDTM and ADaM data set description files and the generation of TFLs;

3. Responsible for verifying SDTM, ADaM and TFLs;

4. Responsible for the annotation and verification of the case report form;

5. Participate in the management of project resources/time schedule/budget;

6. Improve the department’s existing code to ensure the stability and advancement of the department’s programming technology;

7. According to the project test plan, be responsible for quality analysis and issue related test reports.

Professional：

Clinical medicine, pharmacy, public health, preventive medicine, nursing, biostatistics and other medicine-related majors;

Have more than 3 years of relevant project management experience in pharmaceutical company/CRO clinical trial data management;

Familiar with the construction process of mainstream EDC;

Familiar with common systems in the field of clinical data management, familiar with GCP and related requirements

Job description:

1. Independently complete various tasks of data management, including but not limited to reviewing plan data management related content, drafting data management plans and reports, designing CRF, drafting database construction instructions and data verification plans, database testing, and external data consistency verification , SAE consistency comparison, question management, medical coding, document management, database lock and delivery, etc.;

2. Independently lead the data management of the project, including project team formation and training, internal and external communication of the project department, progress control, supplier management, contract review, key time point data delivery (interim analysis, IDMC, database lock library).

Professional：

Statistics, epidemiology and other related majors, with more than 3 years of biostatistics related experience in the pharmaceutical industry;

Familiar with the biostatistics technical guidelines related to ICH and NMPA clinical trials;

Able to use SAS, R and other statistical software proficiently

Job description:

1. Participate in the design of clinical trials, and be responsible for writing the statistical content of the clinical trial plan;

2. Calculate the sample size of clinical research and formulate a randomization plan;

3. Responsible for the statistical analysis plan and the statistical analysis of clinical trials; compile the program to generate statistical graphs, tables or data sets according to the analysis needs, as well as the corresponding description files or reports;

4. Review data management related documents, including but not limited to CRF, electronic data entry guide, data verification plan, and external data transmission protocol;

5. Provide statistical support for the writing of clinical summary reports and support NDA submission.