rc

Clinical project manager

Job Responsibilities:

1. Clinical trial project management: Responsible for the clinical trial project management of the company's products, carry out comprehensive quality control and progress management, and ensure that the project is carried out in strict accordance with GCP, SOP, test plan and Chinese laws and regulations.

2. Clinical trial data management: Responsible for assisting in organizing researchers and statistical experts to discuss clinical trial protocols, and writing, reviewing and revising clinical trial protocols and their ancillary documents, and reviewing and revising clinical trial reports.

3. Organizing meetings: responsible for the research and screening of research units, negotiation of agreements, and holding meetings at various stages of clinical trials.

4. Develop a project plan: According to the contract and the requirements of the clinical trial plan, formulate a project management plan, determine the scope of responsibility of the clinical trial, team members, progress plan, financial budget, etc., and continuously review the project management plan during the project. and modification.

5. Manage the clinical monitor team: including training clinical monitors (including trial protocol, ICF, CRF, research medical records, investigator memorandum cards, etc.), reviewing monitoring reports, and rationalizing the work of clinical monitors Division of labor, review the progress submitted by the clinical monitor and the progress of the project, and coordinate the overall progress of the project.

6. Coordination and communication: Coordinate communication among research centers, CRO companies, data managers and statistical analysts.

7. Emergency management: deal with emergency emergencies in the project (such as SAE handling) in a timely manner, and provide necessary project support for project team members (such as clinical monitors, senior clinical monitors and other project team members).

8. Clinical project verification: formulate a project verification plan, deploy department personnel to carry out the company's clinical trial project sponsor verification, strengthen data management, collect data in a timely manner, and ensure the authenticity and integrity of the data.

job requirements:

1. Bachelor degree or above; biology, medicine, pharmacy, clinical science and other related majors;

2. More than 5 years working experience as a clinical monitor or more than 3 years clinical project management experience

3. Familiar with regulatory requirements, have good communication skills, be familiar with relevant product knowledge, have the ability to read images, be familiar with imaging analysis and pathological analysis, and have good training capabilities.

4. Able to travel frequently.

Interested parties please send your resume to: rwang@ametcorp.com

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Clinical project manager

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