Celerion
1001 - 5000 employees
Founded 1971
🏥 Healthcare
🧬 Biotechnology
💊 Pharmaceuticals
Healthcare • Biotechnology • Pharmaceuticals
Celerion is a global leader in clinical research services with a focus on accelerating drug development through translational medicine. The company offers a range of services including early phase clinical trials, bioanalytical sciences, PK/PD studies, biomarkers, and regulatory affairs. Celerion is dedicated to getting drugs to market faster by leveraging their experience and innovative research strategies. Their expertise covers various therapeutic areas such as oncology, metabolic and respiratory diseases, biosimilars, and vaccines. With over 40 years of experience, Celerion has been recognized for their leadership in the clinical research organization (CRO) space and is committed to science and technology-driven innovations that advance healthcare solutions globally.
Trial Master Files Representative
🔥 18 hours ago
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Celerion
1001 - 5000 employees
Founded 1971
🏥 Healthcare
🧬 Biotechnology
💊 Pharmaceuticals
Healthcare • Biotechnology • Pharmaceuticals
Celerion is a global leader in clinical research services with a focus on accelerating drug development through translational medicine. The company offers a range of services including early phase clinical trials, bioanalytical sciences, PK/PD studies, biomarkers, and regulatory affairs. Celerion is dedicated to getting drugs to market faster by leveraging their experience and innovative research strategies. Their expertise covers various therapeutic areas such as oncology, metabolic and respiratory diseases, biosimilars, and vaccines. With over 40 years of experience, Celerion has been recognized for their leadership in the clinical research organization (CRO) space and is committed to science and technology-driven innovations that advance healthcare solutions globally.
📋 Description
• Prepare and ensure completeness of Trial Master Files (TMF) for internal and external studies • Meet Sponsor-negotiated TMF service specifications • Maintain the TMF • Create file structures and index contents • Communicate with client Sponsors, Project Managers, monitors, sites, and other study contacts • Ensure compliance with protocol and regulatory/local requirements
🎯 Requirements
• Bachelor's degree in related field such as science, nursing, or other biomedical discipline • Experience in clinical research and/or Trial Master Files preferred • Minimum 1 year document management experience • Excellent interpersonal and oral/written communication skills • Highly organized and collaborative • Proficient computer skills, i.e., MS Word, Excel, PowerPoint • Ability to manage multiple priorities
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