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
Leadership & Oversight: Lead and oversee centralized monitoring activities and clinical deliverables across assigned studies.
Study Management: Manage study oversight from start‑up to closeout, including risk assessment, mitigation planning, and operational issue resolution.
Metrics & Analysis: Review site and study metrics, trends, Key Risk Indicators (KRIs), and data alerts; implement corrective actions as needed.
Strategy Development: Support the development of monitoring strategies, analytics plans, and study management tools.
Data Integrity: Oversee subject‑level data review quality and ensure audit‑ready documentation.
Cross-functional Collaboration: Serve as the primary contact for assigned deliverables and collaborate with cross‑functional teams including CRAs, CTAs, CMS, and project management.
Mentorship: Provide leadership, coaching, and mentoring to centralized monitoring staff and technical solution specialists.
Financial Support: Support finance‑related study activities, investigator payments, audits, and inspections.
Compliance: Ensure compliance with study protocols, regulatory requirements, and central monitoring plans.
Qualifications and Skills
Education: Bachelor’s degree in life sciences, clinical sciences, or a related field.
Experience: Minimum 3-5 years of relevant clinical research experience.
Knowledge: Strong knowledge of ICH‑GCP, clinical trial conduct, and clinical systems.
Communication: Excellent communication skills with a good command of the English language.
Problem-solving: Proven leadership, communication, and problem‑solving skills.
Environment: Ability to manage multiple projects, teams, and priorities in a global environment.
Expertise: Strong therapeutic, protocol, and data‑review expertise; detail‑oriented with a strong quality focus.
How to Apply
Interested and qualified candidates should apply online through the IQVIA careers portal on jobs.iqvia.com.
