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In this role you will review and ensure the medical accuracy and completeness of clinical safety data across trials, collaborating with study teams to support safety assessments. You will help set up study start-up standards, review patient data, and prepare safety narratives and meetings. You’ll drive data quality and consistency, contributing to the interpretation of safety information for physicians and scientists. This position offers hands-on impact in a general, cross-functional environment within TRISARC.
Compensaciones / Beneficios
• Ensure consistent processes and efficient review of critical clinical/safety data
• Review patient-level clinical/safety data for medical accuracy, completeness, and coding consistency; generate queries as needed
• Prepare aggregated data visualizations and facilitate study-level safety data reviews
• Contribute to study start-up activities and tool/document setup
• Serve as a member of the Extended Study Team and report on TRISARC deliverables
• Support standardized high-level data review and medical evaluation with study physicians/scientists
• Escalate urgent medical cases to study physician/medical scientist as appropriate
• Provide input on automated and handwritten patient narratives and quality control
• Lead quality of own deliverables and assist with training and continuous improvement
• Perform tasks assigned by Directors and contribute to non-drug project work
Responsabilidades
• Educational degree in Life Science or equivalent field (BSc/MSc/PhD)
• Minimum two years of experience in clinical studies and/or study safety methodology
• Understanding xqbhyrx of clinical study and drug development process
• Knowledge of ICH/GCP guidelines and SAE reporting requirements
• Strong analytical skills and ability to summarize complex information concisely
• Excellent time management and ability to multitask under deadlines
• Very good interpersonal and communication skills
• Team player with ability to work cross-functionally in global studies
• Change management mindset and willingness to adapt to new processes
• Computer proficiency and fluent English
Requisitos principales
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