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gcp edc sdr sdv regulatory complianceπ Description
- Lead planning, execution, and monitoring of clinical studies for Neuralink's BCI trials.
- Conduct site initiation, monitoring, and close-out visits.
- Ensure protocol and regulatory compliance with GCP, ISO 14155, and FDA regs.
- Collaborate with Clinical Operations, Data Management, Regulatory, and QA teams.
- Travel up to 30% domestically and internationally to sites.
π― Requirements
- Bachelor's degree in life sciences, engineering, or related field
- 5+ years of clinical research experience (device experience preferred)
- Working knowledge of GCP (ICH E6), ISO 14155, and applicable FDA regulations
- Experience with electronic data capture (EDC) systems
- Strong understanding of clinical trial processes, monitoring and site management
- Up to 30% travel (domestic and international)
π Benefits
- Medical, dental, and vision insurance
- Paid holidays
- Commuter benefits
- Meals provided
- Equity (RSUs) for full-time employees
- 401(k) plan
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