Clinical Project Manager II / Senior Clinical Project Manager

Role: Senior or Clinical Project Manager leading local/regional clinical trials for biopharma development, with a focus on regenerative medicine and organ transplantation therapies. Responsibilities: oversee entire trial lifecycle, ensure adherence to timelines, budgets, quality standards, and compliance with GCP/ICH; coordinate with cross-functional teams, vendors, and investigators; manage study documentation, protocols, and training; monitor KPIs and address issues proactively; contribute to study design, policies, and SOPs; and oversee vendor relationships. Requirements: Bachelor's degree with 8+ years (PM II) or 10+ years (Senior) of clinical study management experience in CRO/pharma; strong knowledge of GCP/ICH; proficiency with EDC, CTMS, MS Office; excellent communication skills; ability to handle high workloads and work independently and cross-functionally. Preferred: Master’s degree; 3+ years in biopharma research roles like CRA or Clinical Manager; RN licensure; experience across all clinical phases. High-Value: experience in regenerative medicine, organ transplant therapies, or rare disease indications; working in a regulated clinical environment; trial management for biologics or advanced modalities. Location: Durham, NC with hybrid schedule; travel up to 30%.