Clinical Study Manager
$140,000–$160,000 year
On-site · Aliso Viejo, California, United States
Job Summary
The Clinical Study Manager is responsible for managing day-to-day clinical study activities, supporting the planning and execution of clinical studies, and contributing to the development and review of clinical study documents. Key responsibilities include ensuring compliance with regulations, monitoring study progress, and coordinating cross-functional activities. The ideal candidate should have 8-10 years of relevant experience, a bachelor’s degree in a related field, and a strong understanding of clinical trial regulations.
Required Qualifications
- Approximately 8–10 years of clinical research or clinical study management experience within the pharmaceutical, biotech, or medical device industry.
- Bachelor’s degree in a life sciences or related field preferred.
- Experience supporting or managing clinical trials, including protocol execution, site oversight, vendor coordination, and study documentation.
Desired Qualifications
- Strong understanding of clinical trial regulations, including ICH-GCP and applicable FDA and international regulatory guidelines.
- Experience supporting regulatory submissions such as INDs, IDEs, amendments, or annual reports preferred.
- Ability to work effectively in a cross-functional, matrixed environment while managing multiple study priorities.
- Strong organizational, communication, and problem-solving skills with attention to detail.
Additional Requirements
- SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.
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