Related skills
gcp clinical trials ich guidelines sops fda regulations📋 Description
- Lead clinical research operations across trials and geographies.
- Oversee CROs to align with study goals, budget, and timelines.
- Manage junior staff and ensure project success.
- Ensure SOPs and regulatory compliance across trials.
- Drive data collection, analysis, and reporting for trials.
- Coordinate global trials across time zones.
🎯 Requirements
- Bachelor's degree in life sciences or related field.
- 8+ years in operational management of multi-phase clinical research.
- Knowledge of GCP, FDA regulations, and ICH guidelines.
- Experience with IND and CTA filing processes.
- Willingness to travel up to 20% per month.
- Strong leadership and cross-functional collaboration.
🎁 Benefits
- Medical, dental, and vision insurance.
- 401(k) with company match.
- Equity opportunities and annual bonus potential.
- Unlimited vacation and parental leave.
- Onsite meals: breakfast and lunch for onsite employees.
- Employee assistance program and life and disability insurance.
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