
Clinical Operations Director
2 days ago
Senior Clinical Data Manager
We are seeking a highly experienced professional to oversee the planning, execution, and delivery of clinical trials.
- A minimum of 10-15 years of experience in clinical trial/data management and data operations is required.
- At least 4-5 years of people management (preferred) experience with proven supervisory skills is expected.
- Extensive experience with CTMS platforms, including CRIO, RT CTMS, Veeva Vault CTMS, or similar systems, is necessary.
The Senior Clinical Data Manager will be responsible for overseeing the entire clinical trial process.
- Key Responsibilities:
- CTMS configuration and administration skills are essential.
- Deep knowledge of EDC platforms and system integrations is required.
- Strong understanding of regulatory requirements, including HIPAA, FDA, EMA, and ICH-GCP, is necessary.
- Experience with electronic systems validation and 21 CFR Part 11 compliance is essential.
What We Offer:
A competitive salary and benefits package to successful applicants.
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