Clinical Trial Manager - United States
3 days ago
Job description
BrainChild Bio, Inc. is seeking a motivated, detail-oriented, and process-driven Clinical Trial Manager (CTM) who will be a key member of the Clinical Development & Operations Team, reporting directly to the Director of Clinical Operations. This role is responsible for the day-to-day operational leadership and oversight of BrainChild Bio's CAR T cell therapy clinical trials, ensuring studies are executed with precision, compliance, and operational excellence. The CTM serves as the central operational hub across internal teams, CRO partners, clinical sites, and other vendors to drive timelines, manage study execution, and ensure cross-functional alignment and accountability. This role is critical to maintaining subject safety, data integrity, vendor performance, and consistent adherence to BrainChild Bio clinical operations processes within complex CAR T trial environments. This position is remote, with minimal domestic travel (10–20%) to headquarters and the potential to provide on-site clinical trial site support as needed.Key Responsibilities:
-
Planning & Study Execution
- Lead operational study execution throughout trial lifecycle, including but not limited to, 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, implementing practical systems to track and communicate study progress, identify and mitigate risk, and drive resolution of operational issues while contributing to the development and refinement of Clinical Operations processes, templates, and 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 throughout the study Vendor & Clinical Monitoring Oversight
- Provide operational oversight of CRO and other study vendors, serving as a key bridge between internal teams and external partners (including clinical sites) to ensure aligned trial execution, quality performance, and accountability to agreed-upon processes and deliverables.
- Lead vendor meetings, track commitments, and ensure timely resolution of issues and action items
- Review clinical monitoring reports (as needed) to identify trends, assess site/CRA performance, and escalate site- and study-level risks appropriately Cross-Functional Leadership & Collaboration
- Lead and coordinate cross-functional study team workstreams (including Clinical Operations, Patient Operations, Data Management, Medical Monitoring, Regulatory, Quality, and external partners) to drive aligned trial execution
- Facilitate effective communication across internal teams, including meeting leadership, meeting minute compilation, documentation of decisions, and follow-through on action items to resolution
- Identify operational gaps and drive continuous process improvement initiatives through cross-functional collaboration, ensuring consistent execution as the organization and studies evolve
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 with recent experience managing complex oncology and/or pediatric trials; autologous cell therapy experience strongly preferred
- Demonstrated experience providing operational oversight of CRO-managed studies including accountability for timelines, quality, and adherence to sponsor expectations
- Solid understanding of study start-up processes including site activation, IRB/IBC and other institutional committee submissions, and site training coordination
- Strong knowledge of ICH-GCP, CFR, and applicable regulatory requirements governing clinical trial conduct
- Proven ability to organize, track, and manage complex clinical trial activities, timelines, dependencies, and ownership of deliverables in fast-moving studies; prior experience in small, constantly evolving biotech start-up environment is a plus
- Proficiency with clinical project management tools (e.g., MS Project, Smartsheet, etc.) and familiarity with common clinical trial systems (EDC, CTMS, dashboards, vendor portals)
- Experience contributing to and leading development of study-level operational plans to support high-quality trial execution and risk management
- Strong written and verbal communication skills, with the ability to document decisions, escalations, action items, and study status to drive alignment and accountability; willingness to travel domestically ~10–20% as needed
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