Manager, Centralized Monitoring

About the role

The Manager, Centralized Monitoring leads a team of 8‑20 professionals to execute site, regional and study‑level monitoring activities, ensuring risk‑based oversight and compliance with client expectations.

Key responsibilities

• Review trip reports, identify risks, trends, protocol deviations and safety concerns, and communicate findings to study teams.
• Act as liaison between CRAs, CTLs and Project Managers to support timely issue escalation and resolution.
• Develop and maintain trip‑report templates, central monitoring plans, configuration plans and related controlled documents.
• Configure central monitoring tools, set risk factor thresholds, perform user‑acceptance testing and oversee dashboard analytics.
• Lead a portfolio of studies, provide technical leadership, and support PMO activities such as risk registers and impact reports.
• Drive continuous improvement using LEAN and Six Sigma, contribute to SOP development and process mapping.

Required profile

• University degree in Life Sciences or related field (or equivalent experience).
• 2 years of trip‑report or centralized monitoring experience and 10‑12 years of overall clinical research experience.
• Strong analytical, problem‑solving and interpersonal skills with proven people‑leadership ability.
• Fluent English and local language proficiency.

Required skills

• ICH‑GCP knowledge and clinical research regulatory requirements.
• Advanced MS Office (Word, Excel, PowerPoint) proficiency.
• Experience with central monitoring tools, eTMF reconciliation, EDC and CTMS data sources.
• Dashboard design, data visualization and risk‑assessment methodology.
• LEAN and Six Sigma process‑improvement techniques.