Clinical Trial Manager
About Character Biosciences
Role
Reports to
Department
Team
Level
Location
The Opportunity
Study Execution & Delivery
- Trial Management: Own day-to-day operational delivery of one or more clinical trials, driving timelines, quality, and issue resolution from startup through close-out
- Study Planning: Develop and maintain study timelines, clinical plans, risk mitigation plans, and operational trackers, escalating issues before they affect delivery
- Vendor & Site Oversight: Manage CROs, central labs, imaging vendors, and site performance, holding vendors accountable to scope, quality, and timelines
- Enrollment & Monitoring: Track enrollment, monitoring visit completion, and data quality metrics, driving corrective action where needed
Compliance, Documentation & Cross-Functional Collaboration
- GCP Compliance: Ensure studies are conducted in accordance with GCP, the protocol, and applicable regulations
- Trial Master File: Maintain trial master file completeness and inspection readiness in partnership with study team members
- Budget Management: Track study-level spend against budget, flagging variances and supporting invoice and payment review
- Cross-Functional Partnership: Partner with relevant cross-functional stakeholders to keep study execution aligned with program strategy
- Status Reporting: Provide clear, timely updates on study status, risks, and timelines to the program leadership
About You
You bring strong command of clinical trial execution and are comfortable operating independently, owning a study or major workstream from startup through close-out. You anticipate problems before they become blockers, know how to hold vendors and sites accountable, and can flex between the details of day-to-day execution and the bigger picture of what a study needs to succeed.
You are organized, communicative, and thrive in a fast-moving, resource-lean environment where you're trusted to run with your studies. You build strong working relationships with cross-functional partners and external vendors alike, and you bring the judgment to know when to escalate versus solve independently. Like us, you value integrity, individual accountability, team camaraderie, open communication, and a commitment to continuous learning and operational excellence.
- Typically 3-5 years of Clinical Operations experience, including hands-on study startup, vendor oversight, and compliance management
- Bachelor's degree required; advanced degree helpful but not required
- Strong command of clinical trial execution across study phases; ophthalmology or retina experience strongly preferred
- Proven experience managing CROs, vendors, and sites, with a solid understanding of GCP and clinical trial regulations; regulatory agency inspection experience preferred
- Ability to lead cross-functional study teams and interface directly with external vendors and sites
- Strong organizational and communication skills; able to balance competing priorities across studies
- High integrity, high reliability, and comfort operating with a high degree of independence
Compensation & Benefits
EEO Statement
Work Authorization
Not included in the source posting: what you'll do, qualifications.
Skills
Who can apply
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