
Senior Clinical Data Strategist
3 days ago
**Job Overview**
We seek a highly skilled Senior Clinical Data Manager to lead our clinical trial data management efforts.
- Oversee the entire lifecycle of clinical trials, from planning to close-out.
- Develop and implement data management strategies to ensure accuracy and efficiency.
- Lead cross-functional teams in CTMS configuration, EDC system management, and electronic systems validation.
- Maintain compliance with regulatory requirements (HIPAA, FDA, EMA, ICH-GCP).
Our ideal candidate will have:
- 10-15 years of experience in clinical trial/data management and data operations.
- 4-5 years of people management experience with proven supervisory skills.
- Extensive experience with CTMS platforms (CRIO, RT CTMS, Veeva Vault CTMS).
- Strong background in EDC systems management and clinical data operations.
- Experience in pharmaceutical, biotechnology, or CRO environment across multiple therapeutic areas.
**Technical Requirements:**
- CTMS configuration and administration skills.
- Deep knowledge of EDC platforms and system integrations.
- Strong understanding of regulatory requirements.
- Experience with electronic systems validation and 21 CFR Part 11 compliance.
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