The Centralized Monitoring Lead (CML) provides leadership and oversight for centralized monitoring activities across assigned studies. Working closely with project teams, the CML ensures high‑quality clinical delivery, risk management, issue escalation, and compliance with ICH‑GCP, SOPs, and regulatory requirements. This role drives centralized review strategies, supports analytics and study management plans, and guides clinical and technical teams to ensure subject safety, data integrity, and timely project execution. Key Responsibilities: Lead and oversee centralized monitoring activities and clinical deliverables across assigned studies. Manage study oversight from start‑up to closeout, including risk assessment, mitigation planning, and operational issue resolution. Review site and study metrics, trends, KRIs, and data alerts, and implement corrective actions as needed. Support development of monitoring strategies, analytics plans, and study management tools. Oversee subject‑level data review quality and ensure audit‑ready documentation. Serve as primary contact for assigned deliverables and collaborate with cross‑functional teams (CRAs, CTAs, CMS, project management). Provide leadership, coaching, and mentoring to centralized monitoring staff and technical solution specialists. Support finance‑related study activities, investigator payments, audits, and inspections. Ensure compliance with protocol, regulatory requirements, and central monitoring plans. Qualifications and Skills: Bachelor’s degree in life sciences, clinical sciences or related field. Minimum 3-5 years of relevant clinical research experience. Strong knowledge of ICH‑GCP, clinical trial conduct, and clinical systems. Strong communication skills including good command of English language. Proven leadership, communication, and problem‑solving skills. Ability to manage multiple projects, teams, and priorities in a global environment. Strong therapeutic, protocol, and data‑review expertise; detail‑oriented with strong quality focus.
