Medical Monitor
Core
Provide medical oversight for Alzheimer's disease clinical trials, ensuring conduct, recording, and reporting align with protocols, SOPs, GCP, and regulatory requirements.
Role type
Medical Monitor (Clinical Research)
Builds
Clinical trial data and safety reports for Alzheimer's disease treatments
Domain
Biopharmaceuticals / Clinical Research / Alzheimer's Disease
Required skills
Clinical research concepts, FDA regulations, ICH Guidelines, MedDRA/WHODrug coding, Safety Management Plans, Medical Monitoring Plans, Risk Management Plans, Protocol deviation assessment, AE/SAE evaluation
Preferred skills
Medical degree, Alzheimer's disease knowledge, Drug development process understanding, Cross-functional team interaction, Scientific manuscript writing
Technologies
MedDRA, WHODrug
Responsibilities
Support medical monitoring during study conduct, evaluate protocol deviations, communicate with site investigators on safety issues, contribute to safety and monitoring plans, assist in MedDRA/WHODrug coding, oversee Medical Safety Specialist team, interact with industry/academic partners, assist in scientific manuscript writing
Seniority
Mid-level, hands-on IC