Lead and develop a team of Clinical Research Associates (CRAs), supporting their professional development and ensuring high performance
Oversee and manage clinical trial site activities within the region, including site selection, initiation, monitoring, close-out, and issue resolution, ensuring adherence to study protocols and timelines
Ensure all regional site operations activities comply with Good Clinical Practice (GCP), US FDA regulations, applicable local requirements, and company Standard Operating Procedures (SOPs)
Monitor regional site performance against key metrics (e.g., enrollment, data quality, monitoring visit frequency) and implement corrective actions as needed
Serve as the primary point of contact and escalation for CRAs and clinical sites within the region, troubleshooting operational issues
Collaborate closely with the Senior Director, Clinical Site Operations, other regional managers, and cross-functional teams (e.g., Project Management, Regulatory Affairs) to align regional activities with overall clinical strategy and goals
Contribute to the development and implementation of regional strategies, processes, and training for clinical site operations

Requirements

Bachelor’s Degree in field with 6+ years of experience or a Master’s Degree with 4+ years of experience or PhD degree with 2+ years of experience
Two plus (2+) year leading teams and managing people
Knowledge and experience with GCP and global IVD medical device or pharmaceutical regulations

Benefits

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical trial managementsite selectionsite initiationsite monitoringsite close-outissue resolutiondata quality monitoringperformance metricsregional strategy developmenttraining implementation

Soft Skills

leadershipteam managementcommunicationcollaborationproblem-solvingprofessional developmentoperational troubleshootingcross-functional teamworkstrategic alignmentperformance management

Certifications

Good Clinical Practice (GCP)