
Senior Clinical Data Strategist
1 day ago
Job Overview
We are seeking an accomplished Senior Clinical Data Manager to lead our clinical trial and data management operations. This role requires a minimum of 10-15 years of experience in clinical trials, CTMS platforms, and EDC systems management.
Main Responsibilities
- Oversee the implementation of efficient data collection and processing strategies across clinical trial teams.
- Configure and administer CTMS platforms (CRIO or similar) to support trial operations, ensuring seamless integration with existing systems.
- Manage EDC systems integrations, maintaining regulatory compliance with HIPAA, FDA, EMA, and ICH-GCP standards.
- Evaluate electronic system validation and ensure 21 CFR Part 11 compliance for data integrity.
Technical Expertise Required
- CTMS configuration and administration skills (CRIO is preferred)
- Deep understanding of EDC platforms and system integrations
- Strong grasp of regulatory requirements and industry best practices
- Experience with electronic systems validation and implementation
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