Clinical Trial Manager
New
A
AvomindDigital Cardiology
United StatesFull-TimeMiddle
SalaryCompetitive pay plus meaningful equity
Apply NowOpens the employer's application page
Job Details
- Languages
- English
- Experience
- 5+ years in clinical research, including 3+ years in US FDA-regulated devices
- Required Skills
- HIPAA
Requirements
- Degree in life sciences, nursing, medicine, biomedical engineering or a related field.
- 5+ years experience in clinical research.
- 3+ years experience in US FDA-regulated devices.
- Familiarity with SaMD clinical trials.
- Hands-on experience with full IRB submission lifecycle.
- Hands-on experience managing US multicenter trials from start-up through closure.
- Working knowledge of 21 CFR Parts 812, 50, 56 and 11, ICH-GCP, ISO 14155, and HIPAA.
- Practical experience with EDC and eTMF systems.
- Strong stakeholder management skills across academic sites and health systems.
- Fluency in English.
Responsibilities
- Lead trial start-up activities including site selection, agreements, budgets, IRB submissions, and site initiation.
- Drive enrollment and protocol adherence in partnership with investigators and coordinators.
- Own the monitoring strategy and conduct remote and on-site monitoring visits.
- Manage study budgets, timelines, and risk registers with direct reporting to the Chief Medical Officer.
- Maintain operational systems including eTMF, EDC, and data cleaning processes.
- Ensure audit and inspection readiness for FDA BIMO and IRB requirements.
- Support European regulatory compliance and maintain SOPs for clinical operations and data management.
View Full Description & ApplyYou'll be redirected to the employer's site
