Site Manager
Core
Oversee day-to-day clinical trial operations at a research site to ensure enrollment goals are met while maintaining adherence to FDA regulations and ICH guidelines.
Role type
Site Manager for clinical research trials
Builds
Clinical trial data and patient enrollment for global health research programs
Domain
Clinical research / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial management, FDA/ICH/GCP compliance, site staff supervision, vendor coordination, recruitment optimization, root cause analysis, CTMS/eREG/IWRS proficiency, medical terminology
Preferred skills
Prior Research Site Management experience, prior Clinical Research Coordinator experience, Research Professional Certification
Technologies
CTMS, eREG, IWRS, electronic data capture, MS Office
Responsibilities
Oversee site staff work to ensure timely data entry and query resolution; Collaborate with Investigators to evaluate protocol feasibility; Coordinate Investigator and Sub-Investigator coverage; Assess and adjust study distribution to coordinators; Build relationships with local providers for trial access; Ensure all required training is completed; Attend study audits and manage follow-up items; Optimize recruitment activities to meet enrollment goals; Participate in Root Cause Analysis and CAPA; Manage site personnel including PTO, performance appraisals, and hiring; Coordinate building and equipment maintenance; Ensure lab follows IATA guidelines.
Seniority
Mid-level manager, hands-on operational leadership