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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 / Beneficios
- 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 xugodme out-of-scope activities to leadership
Responsabilidades
- 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 requirements
Requisitos principales
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📌 SSU CRA II Barcelona. Sponsor dedicated
🏢 Syneos Health
📍 Barcelona
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