Bluejay Diagnostics is a rapidly growing medical device company focusing on rapid near-patient diagnostics. We strive to innovate in ways which completely change the medical decision-making process, ushering in a new era of healthcare. To help us with our mission, we are searching for a Clinical Trial Manager.
- Serve as the liaison to our clinical research sites.
- Manage site set-up, including contracts, CRFs, registrations, and IRB approvals.
- Serve as a resource for site related issues.
- Train clinical site personnel on the use of investigational medical devices.
- Site monitoring, Trial Master File, Essential Documents, audits, data integrity, recruitment, reporting, etc.
- Understanding of cGCP and ICH guidelines.
- Bachelor’s degree or higher.
- Minimum of 3 years of experience as a Clinical Trial Manager.
- ISO 9001, ISO 13485, or ISO 17025 experience (preferred)
- Demonstrate strong organizational, time management, and problem-solving skills.
- Lead groups and work independently, without instruction.
- Excellent communication skills.
- Ability to commute/relocate to our Acton, MA office (Preferred).
- Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject review between employee and manager throughout tenure.
- Paid time off
- Health insurance
- Dental Insurance
- Vision insurance
- Parental leave