Key Responsibilities

• You will perform unblinded monitoring activities in line with ICH-GCP guidelines and applicable regulations, including Investigational Product oversight
• You will ensure protocol compliance, data integrity, and patient safety at assigned sites
• You will maintain accurate and complete study documentation, including eTMF and regulatory files
• You will build strong relationships with site staff, acting as the primary point of contact for site management (pharmacy only)
• You could contribute to audit readiness and ensure inspection preparedness at site level

Required Qualifications

• Bachelor’s degree in Life Sciences or related field (or equivalent experience)
• Initial experience in clinical research as a CRA with at least 1 year of monitoring experience
• Understanding of ICH-GCP guidelines and clinical trial processes
• Strong interest and knowledge in unblinded study conduct and Investigational Product management
• Fluency in German and English (written and spoken)
• Willingness to travel within the Ruhrgebiet or Frankfurt region and across Germany as required
• Strong organizational skills with attention to detail

What We Offer

• Opportunity to work in a sponsor-dedicated environment on innovative studies
• Structured onboarding and continuous development programs
• Flexible working model supporting work-life balance
• Access to global career growth opportunities within clinical operations
• Inclusive and collaborative culture with employee resource groups and wellbeing initiatives

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