Position: CTMS Data Management Analyst
Client: Large Healthcare Client
Location: Detroit, MI (Remote)
Duration: 3 months, through end of 2024
Start: ASAP
Our large healthcare client is looking for a technical analyst with specific expertise in clinical trial management systems (CTMS), particularly OnCore and E-Reg.
Below is a brief overview of the skills and expertise:
1. OnCore and E-Reg Proficiency:
- Hands-on experience with OnCore for managing clinical trials, including navigation, reporting, and data entry.
- Familiarity with E-Reg for regulatory document management.
2. IRB Review Process:
- Knowledge of Institutional Review Board (IRB) processes and requirements.
- Ability to enter and track IRB submissions and reviews efficiently.
3. CTMS Functionality:
- Experience entering and managing patient and subject data within a CTMS.
- Understanding of protocol compliance and data integrity requirements.
4. Data Management:
- Skills in ensuring data accuracy and completeness.
- Familiarity with data extraction and reporting for clinical trials.
5. Collaboration Skills:
- Ability to work closely with clinical teams, IRB personnel, and other stakeholders.
- Strong communication skills to convey technical information clearly.
6. Problem-Solving Abilities:
- Capability to troubleshoot issues related to system functionality and data management.
7. Regulatory Knowledge:
- Understanding of relevant regulatory requirements (e.g., FDA, ICH-GCP) impacting clinical trial processes.
