Clinical Research Project Manager (PM/Sr PM)

Kelly Science & Clinical is seeking a Senior Clinical Project Manager for a direct-hire position at a clinical-stage biotech company focused on developing neuroprotective therapeutics in ophthalmology. The role involves overseeing end-to-end trial management for global Phase 1 and 2 studies, ensuring compliance and efficient execution in collaboration with clinical trial sites and vendors.

Responsibilities:

• Manage clinical trials to ensure completion on time and compliance with CFR, ICH/GCP, and company SOPs
• Coordinate activities across all study phases, including planning, site qualification, start-up, enrollment, monitoring, and closeout
• Develop and review essential study documents and operational tools
• Provide vendor management and oversight, including participation in selection, contracting, and ongoing coordination
• Build relationships with KOLs, PIs, and site staff
• Foster cross-functional collaboration for aligned trial execution
• Support process improvement initiatives and mentor junior team members
• Up to 20% travel may be required, including possible international trips; remote Pacific Time zone work hours strongly preferred

Requirements:

• Bachelor's degree in biomedical or related clinical field required
• 3+ years of clinical operations experience, with at least 2 years direct clinical trial management at a sponsor or CRO
• Minimum 5 years in clinical research/pharma/biotech/medical device industries
• Strong knowledge of FDA/ICH guidelines and GCP
• Exceptional project management, communication, negotiation, and stakeholder management skills
• Leadership, team management, and business acumen
• Experience with remote/hybrid work environments
• Advanced degree preferred
• Retina/ophthalmology and gene therapy experience strongly preferred
• Previous on-site monitoring experience preferred