Note: The job is a remote job and is open to candidates in USA. Character Biosciences is a precision medicine company pioneering targeted therapies for ophthalmology and advancing clinical programs for Dry Age-related Macular Degeneration. The Clinical Trial Manager will lead the day-to-day operational delivery of one or more clinical trials from startup through close-out, managing vendors and sites while ensuring studies remain on time, on budget, and compliant with GCP. The role partners with Medical, Data, Regulatory, and other stakeholders to drive execution and generate clinical evidence for retinal disease therapies.
Responsibilities
- 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
- 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
Skills
- Typically 3-5 years of Clinical Operations experience, including hands-on study startup, vendor oversight, and compliance management
- Bachelor's degree 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
- Applicants must be authorized to work in the United States
- Ophthalmology or retina experience strongly preferred
- Regulatory agency inspection experience preferred
- Bachelor's degree required; advanced degree helpful but not required
Benefits
- Equity
- Strong equity incentives
- Medical
- Dental
- Vision
- 401(k)
- An accrued paid time off policy
Company Overview