Beschreibung

You will drive the success of oncology clinical trials by managing site performance and ensuring strict GCP compliance. Your role combines expert monitoring with mentoring junior staff to maintain high quality standards.

Anforderungen

• •BS in scientific or healthcare discipline preferred
• •At least 3-5 years monitoring experience
• •Experience in oncology/onco-hematology global trials preferred
• •Advanced knowledge of clinical research regulations
• •3-5 years CRA monitoring experience
• •Experience in oncology/onco-hematology trials preferred
• •Excellent communication and interpersonal skills
• •Ability to maintain effective stakeholder relationships
• •Excellent organizational and problem-solving skills
• •Effective time management skills
• •Good command of English and German
• •Efficiency in Microsoft Office and hardware

Aufgaben

• •Execute clinical monitoring per ICH and GCP guidelines
• •Perform site selection and evaluation activities
• •Manage oncology trial initiation and conduct
• •Collaborate with regional study teams on timelines
• •Identify gaps and propose corrective actions
• •Provide local expertise for study start-up
• •Complete therapeutic and protocol-specific training
• •Deliver protocol training to assigned sites
• •Conduct onsite and remote monitoring visits
• •Document site findings and generate follow-up letters
• •Track regulatory submissions and recruitment progress
• •Manage CRF completion and data query resolution
• •Maintain Trial Master Files and Investigator Site Files
• •Ensure inspection readiness for studies and sites
• •Report site progress to Clinical Operations
• •Facilitate site audits and compliance visits
• •Evaluate the integrity of site practices
• •Escalate quality and GCP issues to investigators
• •Mentor and buddy junior clinical research staff
• •Act as escalation point for site-related concerns
• •Review visit reports and identify significant risks
• •Serve as subject matter expert for clinical operations

Tools & Technologien