Title

Clinical Project Specialist

Job description

1. Clinical Trial Project Planning, Management, and Execution

2. Development of Clinical Trial Protocols

3. Preparation of Documentation for Clinical Trial Applications to TFDA/US FDA

4. Coordination and Communication with Regulatory Authorities, including FDA and CDE

5. Collaboration with Hospital Clinical Trial Teams and Contract Research Organizations (CROs)

6. Monitoring and Oversight of Clinical Trial Progress

7. Management of Clinical Trial Project Budget and Timelines

Qualifications

1. Bachelor's degree or higher in Biomedical Science, Biotechnology, Pharmacy, or related fields

2. Over 2 years of experience in writing and reviewing clinical trial reports

3. Experience in new drug project management

4. Ability to quickly read and summarize relevant literature and experimental methods

5. Familiarity with regulations related to new drug clinical trials is preferred

6. Practical experience with US FDA IND submissions is highly desirable

Application Submission

We welcome you to send your application to info@sinedoremed.com.

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