27 oct
|
Syneos Health
|
España
27 oct
Syneos Health
España
Experteer Overview In this role, you monitor clinical sites to ensure regulatory and protocol compliance across drug development programs.
You work within Clinical Solutions, collaborating with cross-functional teams to safeguard data integrity and subject safety in real-world and traditional trials.
You will perform on-site and remote monitoring, contribute to site management plans, and support audits and trial readiness.
This position offers hybrid work in Madrid or Barcelona and a clear path to develop as a skilled monitors professional in a dynamic, patient-focused organization.
Compensaciones / Ventajas
• Perform site qualification, initiation, monitoring, and close-out visits (on-site or remote) with adherence to ICH-GCP, GPP, and SOPs
• Assess site performance and escalate issues; develop action plans with project teams
• Verify informed consent processes and protect subject confidentiality
• Conduct source data review and ensure accurate CRF data entry; manage query resolution
• Manage IP inventory and reconcile storage and labeling per protocol
• Review Investigator Site File and TMF alignment; ensure archiving compliance
• Document activities and support subject recruitment and retention strategies
• Track project scope, budgets,
and timelines; adapt to changing priorities
• Coordinate with site staff and training to ensure compliance and audit readiness
• Participate in investigator meetings, sponsor meetings, and clinical training as required
• Provide input to site-level and project-level quality improvements and monitoring tools
• Utilize data analytics and risk-based monitoring techniques to identify issues and trends
• Prepare for audits and support post-audit actions
• Assist in early identification of suitable sites based on local knowledge in Real World Late Phase
• May train junior staff and mentor site teams
• Ensure travel requirements (up to 75%) are managed professionally Responsabilidades
• Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
• +1 year of independent on-site monitoring
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
• Strong computer skills and willingness to adopt new technologies
• Excellent communication, presentation, and interpersonal skills
• Willingness to travel up to 75% regularly Requisitos principales •
📌 Cra Ii (España)
🏢 Syneos Health
📍 España