12 ago
|
Syneos Health
|
Barcelona
12 ago
Syneos Health
Barcelona
Experteer Overview Lea el resumen de esta oportunidad para comprender qué habilidades, incluidas las habilidades interpersonales relevantes y el dominio de paquetes de software, se requieren. In this role you support clinical monitoring and site management across the study lifecycle, ensuring adherence to ICH-GCP and regulatory standards. You collaborate with cross-functional teams to drive data integrity, patient safety, and audit readiness in Real World Late Phase studies. You will operate both on-site and remotely, managing site relationships and monitoring deliverables to help bring therapies to patients faster. This is a hands-on, impact-driven position at a mission-focused life sciences services company.Compensaciones / Ventajas• Perform site qualification, initiation, monitoring, and close-out visits with regulatory and protocol compliance• Assess site processes, conduct source data review,
and verify CRF data accuracy and completeness• Resolve data queries remotely and on-site to ensure timely closure• Manage investigational product inventory and distribution per protocol• Maintain ISF/TMF integrity and archiving per guidelines• Prepare and participate in Investigator Meetings and sponsor meetings• Support audit readiness and regulatory inspections readiness• Coordinate with sponsors, sites, and cross-functional teams to meet timelines and budgets• Train junior staff and prepare for lifecycle site support in Real World Late Phase• Identify potential sites and communicate xcskxlj out-of-scope activities to leadershipResponsabilidades• Bachelor's degree or RN in related field or equivalent• Knowledge of GCP/ICH guidelines and regulatory requirements• Strong computer skills and ability to adapt to new technologies• Excellent communication, presentation, and interpersonal skills• Ability to travel up to 75%• US-specific site access compliance requirementsRequisitos principales•
📌 SSU CRA II Barcelona. Sponsor dedicated
🏢 Syneos Health
📍 Barcelona