Study Manager
Core
Run and manage Evvy's clinical study portfolio (observational and interventional trials) to generate evidence for AI-powered women's health products.
Role type
Senior Study Manager (Clinical Operations)
Builds
Clinical trials and evidence generation for vaginal microbiome diagnostics and personalized care platform
Domain
Women's health, microbiome, clinical research
Deliverable
production ML models | product features
Required skills
End-to-end study management, multi-site study coordination, PI and site relationship management, IRB submission management, regulatory documentation (ICH-GCP, FDA, HIPAA), clinical data management (eTMF, EDC), study design partnership
Preferred skills
Women's health/OB-GYN/fertility/microbiome domain expertise, CRO experience, AI in clinical research track record, CCRC/CCRP/ACRP certification
Technologies
eTMF, EDC, WCG, Advarra
Responsibilities
Manage study timelines, milestones, and deliverables; serve as primary contact for PIs and clinical sites; oversee site activation, contracting, training, and monitoring; manage sample shipping logistics; maintain regulatory compliance and audit readiness; partner on study design and clinical output integration; report progress to leadership
Seniority
Senior, hands-on IC
