Senior Clinical Research Associate, Vollzeit oder Teilzeit

• Perform site monitoring activities, both on-site and remotely, using a risk-based monitoring approach
• Ensure protocol, ICH-GCP, regulatory, and SOP compliance at investigator sites
• Conduct SDR, SDV, CRF review, and investigational product accountability
• Identify, document, escalate, and follow up on issues through resolution, applying root cause analysis and CAPA principles
• Maintain audit and inspection readiness at assigned sites
• Build collaborative relationships with investigators and site staff
• Document monitoring activities in timely, high-quality reports and follow-up letters
• Maintain communication with sites between visits to support issue resolution and data quality
• Update study systems such as CTMS according to study conventions
• Provide trial status updates and metrics to the Clinical Team Manager
• Support study start-up, investigator identification, site initiation, and study close-out activities
• Participate in investigator meetings, audits, inspections, and project team meetings
• Review site metrics and prioritize monitoring activities based on risk
• Support process improvement initiatives, mentoring activities, and project-specific tasks as assigned

• Bachelor’s degree in a life sciences related field or equivalent qualification
• Minimum 2+ years of experience as a Clinical Research Associate / Monitor
• Valid driver’s license
• Full right to work in Germany
• Fluency in German and English (C1 level); interviews will be conducted in German
• Strong clinical monitoring skills with hands-on RBM experience
• Excellent understanding and application of ICH-GCP and applicable regulations
• Solid therapeutic area knowledge and medical terminology
• Well-developed critical thinking, problem-solving, and root cause analysis skills
• Strong written and verbal communication skills with medical professionals
• High attention to detail and strong organizational skills
• Ability to work independently while contributing effectively to cross-functional teams
• Flexibility and adaptability in a dynamic project environment
• Proficiency in Microsoft Office and ability to learn clinical systems (e.g., CTMS)
• Willingness to travel approximately 50–75% (study-dependent)

• Work on high-quality, global clinical trials across diverse therapeutic areas
• Stable, well-established organization with long-term career opportunities
• Strong collaboration with experienced CTMs and project teams
• Clear development pathways (e.g., Senior CRA, Lead CRA, CTM)
• Flexible working models that support work-life balance
• Permanent employment
• Full-time (40 hours/week) or part-time (32 hours/week) options available