Senior Clinical Trial Manager
New
United StatesFull-TimeSenior
Salary153,000 - 180,000 USD per year
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Job Details
- Experience
- 5+ years pharmaceutical/biotech clinical trial management experience, with at least 2 years in Phase 2
- Required Skills
- Cross-functional Team Leadership
Requirements
- BA/BS degree with 5+ years pharmaceutical/biotech clinical trial management experience, with at least 2 years in Phase 2
- Specific experience in retina studies within ophthalmology therapeutic area
- Proven ability to lead cross-functional teams and manage sites, and vendors independently
- 3+ years of retina specific Clinical Trials operations
- Strong knowledge of ICH/GCP guidelines and regulatory requirements
- Expertise in trial planning, protocol development, and study database setup
- Demonstrated ability to manage sample collection, data reconciliation, and complex assessment schedules
Responsibilities
- Plan and manage day-to-day operations of assigned early-stage retina studies
- Develop operational plans with effective cross-functional communication
- Lead design and development of core study documents (protocols, ICFs, study plans, manuals, reports) and systems setup
- Create and maintain detailed study trackers; Track study metrics and proactively escalate issues impacting quality, timelines, or subject safety
- Collaborate with study teams to identify and select high-quality retina specialists and investigative sites
- Setup and execute effective investigator, site monitor and study team trainings
- Manage complex schedules of ophthalmology-specific assessments and coordinate proper execution; candidate should have a comprehensive understanding of retina specific assessments and imaging modalities, including the appropriate order of procedures and coordination of imaging workflows to support data integrity and minimize assessment variability
- Oversee CROs and key vendors (central imaging, central lab, data management, pharmacovigilance)
- Help support vendor selection, contract negotiation and performance management
- Manage vendor invoice reconciliation
- Develop study oversight plans and conduct ongoing risk assessment and mitigation
- Serve as primary operational contact for clinical sites and internal stakeholders
- Facilitate site engagement and communications to support study milestones
- Oversee lab database and kit builds, sample management processes, and inventory tracking for retinal specimens
- Manage EDC build, CRF development, and data reconciliation throughout study lifecycle
- Oversee investigational product management including distribution and resupply
- Ensure clinical inspection readiness and compliance with quality standards
- Develop essential project documents including manuals, forms, and monitoring tools
- Participate in clinical operations infrastructure development and process improvement initiatives
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