Clinical Trial Manager, CKD

The Impact You’ll Have
- Steer the execution of one or more Phase 2 CKD clinical trials from protocol development through first patient in, interim analysis, database lock, and study report completion.
- Manage external vendors including CROs, additional key vendors, and global investigative sites.
- Ensure adherence to study protocols, SOPs, and ICH GCP by overseeing monitoring activities at investigative sites.
- Coordinate development of study materials (CRFs, ICFs, patient diaries).
- Act as the voice of Clinical Operations on cross-functional teams, including the Study Execution Team (SET).
- Partner with Clinical Operations and Clinical Science to engage therapeutic area KOLs and Investigators.

What We’re Looking For
- Degree in a scientific discipline or health-related field.
- Minimum 4 years clinical research experience, including 2 years as a Clinical Trial Manager at a biopharmaceutical company or CRO.
- Experience planning and executing Phase I–II trials (preferred).
- Proficiency implementing, monitoring, and managing clinical trials from start-up to close-out.
- General knowledge of FDA regulatory requirements and ICH GCP.
- Strong organizational skills; ability to prioritize and multi-task.
- Excellent verbal and written communication skills.
- Demonstrated problem-solving and negotiation abilities.
- Ability to build relationships with internal and external partners.
- Ability to perform a broad range of clinical trial tasks as needed.
- Willingness to travel as necessary.
- Strong computer proficiency (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook).
- Experience with clinical trial databases (e.g., Medidata Rave, Veeva).

Benefits (explicitly stated)
- Competitive medical, dental, and vision insurance; mental health offerings; equity incentive plan; 401(k) match; generous holiday and PTO.

Compensation (explicitly stated)
- Expected annual salary range (San Francisco Bay Area): $143,000–$175,000; eligible for annual performance bonus.