Develop test scripts and execution logs for User Acceptance Testing (UAT);
Database audit;
Perform data review;
Create and maintain Data Management Plan under the supervision of senior members;
Create and maintain Data Validation Plan under the supervision of senior members;
Create and maintain Data Entry Guidelines;
Create Data Handling Plan under the supervision of senior members;
Create Data Transfer Specification under the supervision of senior members;
Perform CRF design and CRF review under the supervision of senior members;
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.
Perform SAE reconciliation;
Perform external data reconciliation in collaboration with programmers;
Other DM tasks as deemed appropriate by senior members.
Other activities/tasks assigned by supervisor.
Qualification:
Bachelor’s degree in clinical/pharmacy/biological/mathematical sciences or related field or nursing degree with 1-3 year clinical experience.
Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
Good understanding of clinical drug development process.