Clinical Project Manager
New
C
CoMindMedical Devices
Remote, US, Eastern or Central Time zoneFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- 3-6 years
- Required Skills
- GCP
Requirements
- 3-6 years of clinical research experience
- Minimum 2 years of experience in medical device clinical trials
- Demonstrated knowledge of FDA regulations (21 CFR 812), ISO 14155, and GCP guidelines
- Hands-on experience managing clinical sites and/or CRO relationships
- Proficiency with EDC, eTMF, and CTMS software
- Strong organizational and documentation skills
- Ability to manage multiple studies simultaneously
Responsibilities
- Develop and maintain clinical project plans, timelines, and budgets
- Lead site feasibility assessments, selection, and CTA negotiations
- Prepare and review study documents like protocols, ICFs, CRFs, and study manuals
- Oversee site initiation, monitoring, and close-out visits
- Manage clinical data activities, including query resolution and data cleaning
- Ensure study compliance with 21 CFR, ISO 14155, and GCP
- Author and review clinical study reports and periodic safety reports
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