Beschreibung

You will drive the success of oncology trials by managing site performance and monitoring data quality. Your role ensures clinical excellence through rigorous site oversight and collaboration.

Anforderungen

• •BS in relevant scientific discipline
• •Minimum 2 years monitoring experience
• •Experience in oncology global trials preferred
• •Understanding of clinical trial processes
• •Knowledge of ICH and regulatory guidelines
• •2 years pharmaceutical/CRO monitoring experience
• •Experience in oncology/hematology trials preferred
• •Excellent communication and interpersonal skills
• •Excellent organizational and multi-tasking skills
• •Fluency in English and German
• •Efficiency in Microsoft Office and Outlook

Aufgaben

• •Execute clinical monitoring at trial sites
• •Adhere to ICH guidelines and GCP standards
• •Perform site selection and initiation activities
• •Monitor oncology and hematology clinical trials
• •Collaborate with the Regional Clinical Operations Manager
• •Maintain study timelines and quality standards
• •Identify gaps and propose corrective actions
• •Support study start-up with local expertise
• •Conduct site identification and feasibility assessments
• •Provide protocol training to assigned sites
• •Perform routine monitoring and closeout visits
• •Complete detailed monitoring visit reports
• •Track regulatory submissions and recruitment progress
• •Manage CRF completion and data query resolution
• •Maintain regular communication with clinical sites
• •Ensure inspection readiness for all studies
• •Facilitate site audits and oversight visits
• •Escalate quality and GCP issues appropriately
• •Attend disease-specific and general CRA training

Tools & Technologien