Clinical Trial Manager/Senior Clinical Trial Manager
Bay Area (Hybrid in South San Francisco)
We're working with a fast growing biotech working in multiple therapeutic areas in phases I-III across six clinical trials.
Position Overview:
This biotech is looking for a Senior / Clinical Trial Manager who will play a pivotal role in driving and managing their ongoing clinical trials and ensuring the success of them. They have an unmatched management team and foster a collaborative work environment.
We've worked with their team for 5+ years and the management team values EPM's candidate submissions as we've placed multiple people with them previously.
Responsibilities:
- Collaborate with our clinical operations team to oversee clinical trials
- Shared responsibility for monitoring overall study integrity, interpreting accumulating data on the safety and efficacy, and ensuring compliance with regulatory requirements in global drug development.
- Interact with our CRO, Clinical Trial Manager, and Project Manager, serving as the lead contact
- Play a key role in maintaining adherence to Good Clinical Practices, pharmacovigilance standards, and all other quality standards throughout the research process
- Actively participate in weekly CRO/Internal team communications, contributing to progress reports and discussions on project risks and strategies.
- Maintain a relationship with CRO Executive Team and other vendors as needed
Experience:
- Bachelor's Degree; an advanced degree in a scientific field is considered advantageous.
- Must have at least 3-4 years' experience in managing clinical operations trials
- Ophthalmology, rare disease, or immunology experience
- Early phase clinical trial management background
- Knowledge of GCPs, ICH guidelines and FDA regulations
- Solid understanding of clinical indications and the drug development process.
Benefits:
- Competitive salary
- Notable leadership and growth opportunities
