Senior Clinical Research Associate, Vollzeit oder Teilzeit

🔥 25 minutes ago

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• 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

🎯 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); 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)

🏖️ Benefits

• 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

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