
Senior Clinical Data Operations Lead
1 day ago
As a Clinical Data Manager, you will be responsible for overseeing the collection, analysis, and interpretation of clinical trial data.
Required Skills & Qualifications:- 10-15 years of experience in clinical trial/data management and data operations with a focus on supervisory skills.
- Minimum 4-5 years of people management experience with proven leadership abilities.
- Extensive experience with CTMS platforms (CRIO, RT CTMS, Veeva Vault CTMS) or similar systems.
- Strong background in EDC systems management and clinical data operations including electronic systems validation and 21 CFR Part 11 compliance.
- Experience in pharmaceutical, biotechnology, or CRO environment across multiple therapeutic areas.
- CTMS configuration and administration skills with knowledge in CRIO advantageous.
- Deep understanding of EDC platforms and system integrations.
- Strong understanding of regulatory requirements including HIPAA, FDA, EMA, ICH-GCP.
This is an exciting opportunity to leverage your expertise in clinical data management and lead a team of professionals in delivering high-quality results. If you are a motivated and organized individual with a passion for data analysis, we encourage you to apply.
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