Senior Clinical Trial Manager (ACH)

Role: Senior Clinical Trial Manager supporting rare disease clinical trials, overseeing study start-up through close-out. Responsibilities: manage CROs, vendors, and sites; coordinate study setup including protocols, systems, and regulatory submissions; ensure compliance with GCP, ICH, FDA regulations; maintain documentation, assist with audits, and support study metrics. Requirements: Bachelor's in life sciences; 8+ years clinical trial support experience, with at least 3 years in a CTM/Sr. CTM role overseeing early phase and global trials; strong project management skills; proficiency with electronic trial systems (eTMF, CTMS, EDC); knowledge of regulatory guidelines; ability to work independently. High-Value: rare disease, clinical trial management, global early-phase studies, regulatory compliance, eTMF/CTMS systems. WorkSetup: remote with periodic in-person collaboration; minimal travel (~5-10%).