Clinical Affairs Manager – IVD

Job not on LinkedIn

November 20

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Logo of Tosoh Bioscience

Tosoh Bioscience

Biotechnology • Science

Tosoh Bioscience is a life-sciences company and subsidiary of Tosoh Corporation that develops and supplies laboratory systems, specialty chromatographic products, and clinical diagnostic instruments. The company offers over 500 products including analytical HPLC columns, chromatographic resins, GPC/SEC instruments for separations and purification, and automated immunoassay and glycohemoglobin analyzers, assays, and reagents for clinical diagnostics. Its products support biomedical research, pharmaceutical purification, clinical testing, water and environmental monitoring, and disease surveillance.

201 - 500 employees

🧬 Biotechnology

🔬 Science

📋 Description

• Planning, execution, and oversight of multiple clinical and analytical studies across various sites • Ensure compliance with all regulatory and contractual requirements • Manage the operational aspects of clinical studies • Develop and evaluate clinical and analytical study protocols • Conduct site monitoring visits and follow-ups • Oversee transmission and review of clinical case data

🎯 Requirements

• 10 + years experience in clinical and analytical study management • 5 + years of clinical research experience in the in-vitro diagnostic medical device industry, including on-site and remote monitoring • Strong knowledge of ICH/GCP as well as CLSI and FDA regulations • Ability to independently develop and apply concepts and techniques in clinical research monitoring

🏖️ Benefits

• Travel Percentage Up to 25% • Health insurance available • Retirement plans available

Apply Now

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