Clinical Trial Manger (Hybrid in Manhattan, NY)
This company is a fast growing biotechnology company that specializing in bringing innovative and enhanced versions of successful CNS treatments to the US market. Their approach is to create a research-focused organization dedicated to generating novel intellectual property related to improved versions of these previously successful CNS drugs.
Position Overview :
The company is looking for a Clinical Trial Manager who will play a pivotal role in driving and managing their ongoing clinical trial Phase 2 programs forward and ensuring the success of it. This candidate will report directly into the Senior Director of Clinical Operations .
- Collaborate with our clinical operations team to oversee our ongoing Phase 2 clinical trial in schizophrenia.
- Shared responsibility for monitoring overall study integrity, interpreting accumulating data on the molecule's 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 with Phase 2 sites to manage enrollment effectively.
- 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.
- Must have a Bachelor's Degree; an advanced degree in a scientific field is considered advantageous.
- Must have at least 3 years' experience in managing clinical operations, specific in CNS indications.
- Experience in schizophrenia clinical trial is a nice to have.
- Knowledge of GCPs, ICH guidelines and FDA regulations
- Solid understanding of clinical indications and the drug development process.
- Must be able to go on site at least 3 days a week in Manhattan, NY.
- Up to 25% travel to 24 sites around the US.
- Competitive salary
- Liquid stock options package.
- Notable leadership and growth opportunities.