Responsibilities:

1. CRF/DCF tracking;
2. Develop test scripts and execution logs for User Acceptance Testing (UAT);
3. Database audit;
4. Perform data review;
5. Create and maintain Data Management Plan under the supervision of senior members;
6. Create and maintain Data Validation Plan under the supervision of senior members;
7. Create and maintain Data Entry Guidelines;
8. Create Data Handling Plan under the supervision of senior members;
9. Create Data Transfer Specification under the supervision of senior members;
10. Perform CRF design and CRF review under the supervision of senior members;
11. Develop database (DB) clinical trial data specifications under the supervision of senior members, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
12. Perform SAE reconciliation;
13. Perform external data reconciliation in collaboration with programmers;
14. Other DM tasks as deemed appropriate by senior members.
15. Other activities/tasks assigned by supervisor.

Qualification:

1. Bachelor’s degree in clinical/pharmacy/biological/mathematical sciences or related field or nursing degree with 1-3 year clinical experience.
2. Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
3. Good understanding of clinical drug development process.