PM-南京科默生物医药有限公司

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Job Responsibilities:

1. Responsible for the project management of various clinical trials conducted by the company, providing comprehensive quality control and progress management for the assigned clinical research projects, ensuring that all trials are strictly conducted in accordance with GCP, SOPs, study protocols, and Chinese laws and regulations.

2. Develop a project management plan based on the contract requirements and clinical trial protocol, defining the scope of responsibilities, team members, progress schedule, financial budget, etc., and continuously review and revise the project management plan as the project progresses.

3. Regularly report on the trial progress according to the contract and submit project progress reports.

4. Review and approve the actual working hours and expenses incurred by project team members during project implementation in accordance with the contract and project plan, ensuring that all tasks are completed within the timeframe and budget agreed upon with the client.

5. Supervise project team members to complete the overall initiation, execution, and closure of clinical trials on time for the assigned projects.

6. Conduct site co-visits for the assigned clinical trials as required by the contract and when necessary, and complete site co-visit reports.

7. Identify, monitor, and promptly address various risks throughout the project, accurately assess the overall impact of corresponding risks on the project, and implement reasonable improvement measures.

8. Ensure the completeness, accuracy, and timeliness of clinical trial project documentation.

9. Serve as the primary liaison for clinical trial projects, representing the company and project team in maintaining timely and effective communication with sponsors, principal investigators, and vendors, ensuring that key project information is accurately and completely conveyed, and fostering and maintaining good relationships with study sites and clients.

10. Handle emergencies in the project promptly and provide training to project team members.

11. Communicate and coordinate with various functional teams regarding the assigned research projects, such as medical writing, data and statistics, and quality assurance personnel.

Job Requirements:

1. Bachelor's degree or above in medicine, pharmacy, or related fields.

2. At least 3 years of CRA experience and 1 year of APM experience.

3. Familiarity with GCP and the phases and requirements of clinical research.

4. Ability to lead a team, with strong interpersonal skills and the capability to coordinate and collaborate across departments.

5. Proficiency in using office software.

Based in:

Nanjing