Found Description
**Job Overview**
The Clinical Data Manager (CDM) is responsible for managing data activities for Phase I-III clinical trials, ensuring compliance with ICH/Good Clinical Practices (GCP) and other relevant guidelines. The CDM ensures trials are completed on time, within budget, and with the highest quality.
**Key Responsibilities**:
- Serve as the primary data management representative on multidisciplinary project teams.
- Communicate key clinical data management metrics (e.g., data entry status, query resolution, and aging) and determine appropriate actions with the study team.
- Review, develop, and write clinical trial documents and manuals, including Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans, and eCRF Completion Guidelines.
- Participate in User Acceptance Testing (UAT) and Quality Control (QC) as needed.
- Collaborate with Clinical Database Programmers to develop Data Flow Charts, Data Transfer Specifications, and Import G...
The Clinical Data Manager (CDM) is responsible for managing data activities for Phase I-III clinical trials, ensuring compliance with ICH/Good Clinical Practices (GCP) and other relevant guidelines. The CDM ensures trials are completed on time, within budget, and with the highest quality.
**Key Responsibilities**:
- Serve as the primary data management representative on multidisciplinary project teams.
- Communicate key clinical data management metrics (e.g., data entry status, query resolution, and aging) and determine appropriate actions with the study team.
- Review, develop, and write clinical trial documents and manuals, including Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans, and eCRF Completion Guidelines.
- Participate in User Acceptance Testing (UAT) and Quality Control (QC) as needed.
- Collaborate with Clinical Database Programmers to develop Data Flow Charts, Data Transfer Specifications, and Import G...