Thermo Fisher Scientific
10,000+ employees
Founded 1956
🧬 Biotechnology
💊 Pharmaceuticals
🔬 Science
Biotechnology • Pharmaceuticals • Science
Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
Senior CRA I/II – Senior Klinischer Monitor
Job not on LinkedIn
🕒 February 10
🗣️🇩🇪 German Required
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Thermo Fisher Scientific
10,000+ employees
Founded 1956
🧬 Biotechnology
💊 Pharmaceuticals
🔬 Science
Biotechnology • Pharmaceuticals • Science
Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
📋 Description
• Perform site monitoring activities (on-site and remote) 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 all assigned sites • Build strong, collaborative relationships with investigators and site staff • Document monitoring activities in timely, high-quality reports and follow-up letters • Maintain ongoing communication with sites between visits to support issue resolution and data quality • Ensure study systems (e.g., CTMS) are updated according to study conventions • Provide trial status updates and metrics to the Clinical Team Manager (CTM) • Support study start-up, investigator identification, site initiation, and study close-out activities as assigned • Participate in investigator meetings, audits, inspections, and project team meetings as required
🎯 Requirements
• 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) • 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)
🏖️ Benefits
• Flexible working models that support work-life balance • Permanent employment • Full-time (40 hours/week) or Part-time (32 hours/week) options available
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