Experteer Overview
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In this role you drive site monitoring and management for multicenter trials within a hybrid, multisponsor setup. You collaborate with site teams to ensure regulatory, ICH-GCP and study protocol adherence while safeguarding data integrity and subject safety. You will manage site qualification, initiation, monitoring, IP handling, and documentation, and support trial readiness and team collaboration. The position offers impact across real-world late-phase studies and global study teams, with a chance to shape monitoring processes and improve trial outcomes.
Compensaciones / Beneficios
• Perform site qualification, initiation, interim monitoring, site management and close-out visits (on-site or remote) with regulatory and protocol compliance
• Verify informed consent and protect subject confidentiality; assess safety and data integrity factors at the site
• Conduct source data review and ensure accurate CRF data; drive timely query resolution
• Manage IP inventory, storage, dispensing, and labeling in line with protocol and GCP/regs
• Review ISF and TMF accuracy; ensure archiving per guidelines
• Document activities via standard project records; support recruitment, retention and awareness strategies
• Track project scope, budgets and timelines; adapt to changing priorities to meet goals
• Prepare for and participate in Investigator Meetings and sponsor meetings; train site personnel as needed
• Support audit readiness and post-audit follow-up actions
• Utilize data analytics and risk-based monitoring to identify issues and trends across sites
Responsabilidades
• Bachelor's degree or RN in related field; equivalent experience
• +1 xpzdshu year of independent on-site monitoring experience
• Knowledge of GCP/ICH guidelines and regulatory requirements
• Strong computer skills and ability to learn new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to travel up to 75% regularly
Requisitos principales
• career development and progression
• supportive line management
• therapeutic area training
• peer recognition
• total rewards program
• inclusive culture
Hay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.