Clinical Trial Manager (CTM)

Role: Clinical Trial Manager (CTM) overseeing medium to large clinical studies in biopharma, focused on cortisol modulation therapies for diseases such as hypercortisolism, oncology, ALS, and liver disease. Responsibilities: independently manage study execution, including start-up, enrollment, monitoring, vendor oversight, and ensuring compliance with GCP, SOPs, and protocols; develop and review key study documents; coordinate CRO/vendor selection and management; oversee regulatory document submissions; and supervise Clinical Research Associates. Requirements: BS/BA or nursing degree; 6+ years’ experience as a CRA or field monitor in biotech, pharma, or CRO; strong knowledge of US GCP/ICH regulations; experience managing clinical trials and vendor relationships; proficient in project management, communication, and regulatory documentation. Preferred qualifications include study management experience and strong organizational skills. HighValue: experience with clinical trials in hypercortisolism, oncology, ALS, or liver disease; managing multi-site studies; familiarity with IND submissions; up to 30% travel; hybrid onsite/remote setup; supervisory responsibilities for clinical operations staff.