Senior Medical Reviewer (Alexion)
Core
Reviewing and monitoring efficacy and safety data from late-phase clinical trials to ensure data integrity and participant safety.
Role type
Senior Medical Reviewer (Clinical Trials)
Builds
Clinical trial data packages for regulatory submission and label indication determination
Domain
Biopharmaceuticals / Clinical Research
Required skills
Medical data review, Safety data analysis, Clinical study design, ICH/GCP guidelines, SAE reporting, Medical coding (MedDRA/WHO DD), Cross-functional collaboration, Mentoring, Quality assurance, Data visualization
Preferred skills
Electronic data capture systems, Query management tools, Risk-Based Monitoring, Data analysis programming (Python/R/SAS), Negotiation
Technologies
JReview, JMP Clinical, Elluminate, Spotfire, MedDRA, WHO DD, Python, R, SAS, Microsoft Power Platform
Responsibilities
Review patient-level clinical/safety data and generate queries, Lead quality assurance of deliverables and oversee junior staff, Prepare aggregated data visualization and facilitate study meetings, Escalate critical findings and adverse events, Support study setup, maintenance, and closure, Develop procedures and training activities
Seniority
Senior, hands-on IC with mentorship responsibilities