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崗位職責(zé):

1. Accountable and responsible medical oversight on assigned projects. When required, actively produce and contribute with clinical/medical input in relevant documentations – such as e.g. IB, clinical trial protocols, CSRs etc.

2. Being able to medical monitor studies as required

3. Supporting the clinical project team / study team with the clinical/medical input and actions required

4. Accountable for clinical/medical deliverables of assigned projects and additions as defined by manager

5. Responsible for the daily operation and management of the Clinical Medicine Department, team building, and personnel management.

6. Lead the team in providing input on scientific clinical research plans and strategies, scientifically position products, and ensure the smooth completion of clinical development projects for the company. Provide medical advice on the strategic planning of the product lifecycle. Support preparations for presentation to management in the clinical research committee

7. Lead clinical/medical contacts with key external experts to effectively enhance the scientific discussions to help determine clinical research, clinical development and clinical positioning / unmet medical need of the company’s products in development.

8. Support and actively contribute when required in writing professional medical application materials for the company

s development projects, such as IND and NDA, and promote the company

s research and development progress. Support the selection of appropriate indications for the company

s research projects to ensure efficient and rapid development.

9. Responsible for clinical research design and writing of Phase I-III clinical study protocols that comply with regulatory requirements, ensuring scientific, operational, and ethical compliance, and consistency with the overall product positioning of the company as by decisions at the clinical research committee and governance bodies.

10. Lead, organize (and contribute when required) the team in planning and implementing medical management and monitoring during the clinical research process, review protocol deviations, provide medical support, and ensure the medical compliance of clinical research, consistency of protocols, and the timeliness, completeness, accuracy, and truthfulness of data.

11. Responsible for supervising/generating the preparation of basic documents for clinical trials (e.g. MM plan, eCRF, PD, SAP etc), organizing the implementation of clinical trial protocols, related medical training, and FAQs.

12. Manage and guide the team in engaging in research interpretation and translation, work closely with the company’s internal translational science department to translate science into clinical opportunity and manage and guide clinical writing clinical research reports and publishing articles, accurately interpret clinical research data, and disseminate research findings.

任職要求:

1. Clinical medicine, basic medicine and other medical related majors；

2. Familiar with internal medicine, surgery, pathophysiology and other related professional knowledge

3. Familiar with clinical trial phase I-III application process

4. Master the strategic requirements of clinical research development plan

5. Proficient in clinical trial protocol design and writing requirements

6. Master the relevant regulations and guidelines of GCP

7. Good command of written and spoken English

8. More than 10 years of MD or clinical development experience in the field of biomedicine, more than 5 years of clinical research experience or corresponding position experience;

9. Have project experience in designing different clinical trial protocols.