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Role Description
This role involves operational leadership and oversight of BrainChild Bio’s CAR T cell therapy clinical trials, ensuring studies are executed with precision, compliance, and operational excellence.
• Serve as the central operational hub across internal teams, CRO partners, clinical sites, and other vendors
• Drive timelines, manage study execution, and ensure cross-functional alignment and accountability
• Maintain subject safety, data integrity, vendor performance, and adherence to clinical operations processes
• Remote position with minimal domestic travel (10–20%)
Key Responsibilities
• Lead operational study execution throughout trial lifecycle, including study timeline development, milestone tracking, budget oversight, vendor coordination, and resource planning
• Ensure study activities are conducted in alignment with protocol, ICH-GCP, regulatory requirements, and BrainChild Bio procedures
• Serve as a subject matter expert in clinical project management tools
• Ensure trial documentation and clinical systems (e.g., EDC, CTMS, TMF) are developed, maintained, and reviewed in an accurate, complete, and audit-ready state
• Provide operational oversight of CRO and other study vendors
• Lead vendor meetings, track commitments, and ensure timely resolution of issues and action items
• Review clinical monitoring reports to identify trends and escalate site- and study-level risks
• Lead and coordinate cross-functional study team workstreams
• Facilitate effective communication across internal teams
• Identify operational gaps and drive continuous process improvement initiatives
Qualifications
• Bachelor’s degree in a scientific or health-related discipline required
• Minimum of 7 years of clinical research experience, including at least 4 years of hands-on clinical trial management in pharma/biotech–sponsored studies
• Demonstrated experience providing operational oversight of CRO-managed studies
• Solid understanding of study start-up processes
• Strong knowledge of ICH-GCP, CFR, and applicable regulatory requirements
• Proven ability to organize, track, and manage complex clinical trial activities
• Proficiency with clinical project management tools (e.g., MS Project, Smartsheet, etc.)
• Experience contributing to and leading development of study-level operational plans
• Strong written and verbal communication skills
Requirements
• Willingness to travel domestically ~10–20% as needed
Benefits
• $135,000 - $155,000 a year