CRA I/II – Klinischer Monitor

Job not on LinkedIn

🕒 May 22

🗣️🇩🇪 German Required

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Logo of Thermo Fisher Scientific

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

• Performs and coordinates all aspects of the clinical monitoring and site management process. • Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. • Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs. • Ensures audit readiness. • Develops collaborative relationships with investigational sites. • Monitors investigator sites with a risk-based monitoring approach, applying root cause analysis, critical thinking and problem-solving skills to identify site processes failure.

🎯 Requirements

• Bachelor's degree in a life sciences related field or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job • Valid driver's license • Full Right to work in Germany • Fluency in English and German language to at least C1 level

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible working hours • Paid time off • Professional development opportunities

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