Clinical Project Manager

CLINICAL PROJECT MANAGER (CPM)

KEY RESPONSIBILITIES

• Own end-to-end operational delivery of one or more CNS studies — scope, timelines, budget, quality, and risk.
• Lead cross-functional execution across clinical operations, data management, biostatistics, safety, regulatory, and clinical supply.
• Manage CROs and functional vendors to milestones, SLAs, and budget; hold partners accountable to the activation and enrollment plan.
• Drive the plan to first patient-in (Q1 2027 target) and subsequent enrollment and database milestones.
• Proactively identify risks and implement mitigations; keep sponsor leadership informed with clear status reporting.
• Champion inspection readiness and GCP compliance across study conduct and the TMF.

REQUIRED QUALIFICATIONS

• 6+ years in clinical trial management with demonstrated project leadership; Phase 2/3 experience.
• Proven delivery managing CROs/vendors, timelines, and budgets on interventional trials.
• Deep ICH-GCP knowledge and US regulatory fluency; strong risk and stakeholder management.
• Bachelor’s in a life-science or related field (advanced degree a plus).

PREFERRED

• CNS / psychiatry / depression program experience; familiarity with rating-scale-driven endpoints (e.g., MADRS) and placebo-response management.
• Experience running multiple concurrent studies and short-duration designs.