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BioAge Labs is seeking an experienced Clinical Trial Manager to lead the planning, execution, oversight, and delivery of clinical studies across Phase I/Ib/II/III programs. Reporting to the VP of Clinical Operations, this role independently manages complex regional and global clinical trials, drives operational strategy, manages study budgets and timelines, provides oversight of CROs and vendors, and ensures inspection readiness and compliance with GCP, ICH, protocol, and regulatory requirements.
Key responsibilities include:
- Independently lead and manage Phase I/Ib/II/III clinical studies of moderate to high complexity, including large regional and/or global trials
- Provide senior clinical operations leadership across the full study lifecycle: startup, enrollment, maintenance, closeout, and inspection readiness
- Drive execution of study operational plans, timelines, budgets, risk mitigation strategies, communication plans, monitoring plans, and vendor oversight
- Serve as primary operational lead for assigned studies and may lead clinical operations workstreams within larger development programs
- Lead cross-functional study teams, facilitate decision-making, and ensure alignment across internal stakeholders, CROs, contractors, vendors, and clinical research sites
- Provide primary CRO and vendor oversight, including performance management, issue escalation, deliverable review, and accountability for quality, budget, and timelines
- Contribute to development, review, and implementation of clinical plans, study budgets, timelines, and operational feasibility assessments
- Identify, assess, and escalate study risks; implement proactive contingency and mitigation strategies
- Oversee clinical systems including EDC, CTMS, eTMF, IWRS, and lab portal
This is a fully remote position available to candidates in any continental US state. The role requires deep expertise in clinical trial operations, regulatory compliance, and vendor management.
