Centralized Monitoring Lead at IQVIA
IQVIA
The Centralized Monitoring Lead (CML) provides leadership and oversight for centralized monitoring activities across assigned studies. Working closely with project teams, the CML ensures highÃÂâÃÂÃÂÃÂÃÂquality clinical delivery, risk management, issue escalation, and compliance with ICHÃÂâÃÂÃÂÃÂÃÂGCP, 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 startÃÂâÃÂÃÂÃÂÃÂup 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 subjectÃÂâÃÂÃÂÃÂÃÂlevel data review quality and ensure auditÃÂâÃÂÃÂÃÂÃÂready documentation.
Serve as primary contact for assigned deliverables and collaborate with crossÃÂâÃÂÃÂÃÂÃÂfunctional teams (CRAs, CTAs, CMS, project management).
Provide leadership, coaching, and mentoring to centralized monitoring staff and technical solution specialists.
Support financeÃÂâÃÂÃÂÃÂÃÂrelated 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 ICHÃÂâÃÂÃÂÃÂÃÂGCP, clinical trial conduct, and clinical systems.
Strong communication skills including good command of English language
Proven leadership, communication, and problemÃÂâÃÂÃÂÃÂÃÂsolving skills.
Ability to manage multiple projects, teams, and priorities in a global environment.
Strong therapeutic, protocol, and dataÃÂâÃÂÃÂÃÂÃÂreview expertise; detailÃÂâÃÂÃÂÃÂÃÂoriented with strong quality focus