Clinical Trial Manager/Senior Clinical Trial Manager
SolenoRedwood City, California, United States
Posted June 18, 2025
145000 - 185000 USD
Full Time
About the Company
Soleno Therapeutics Inc is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases.
Job Description
We are seeking a Clinical Trial Manager/Senior Clinical Trial Manager to lead the operational planning and execution of clinical trials from start-up through close-out, ensuring trials are delivered on time, within budget, and in compliance with regulatory requirements.
Requirements
- Bachelor’s degree in life sciences or related field
- 6 – 8+ years of related clinical trial management experience
- Demonstrated experience with the unique operational and regulatory considerations of all phases, including post-marketing trials
- Rare Disease experience strongly preferred
- Experience in managing outside service providers (e.g., CROs, central laboratories, and other vendors)
- Strong knowledge of FDA, EMA, global regulatory requirements and ICH GCP
- Experience with risk-based quality management and inspection readiness
- Proven ability to manage budget and timelines
- Strong leadership, communication, and problem-solving skills
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
