NAMSA

Clinical Research

• Develop and maintain foundational clinical study materials and tools
• Coordinate team and client review processes
• Create and manage study tracking tools, metrics, systems, and reporting
• Support protocol training, client and site management, and escalation and resolution of site issues
• Establish and monitor project metrics and track project deliverables
• Communicate project status to clients and internal teams
• Facilitate team and sponsor meetings and follow action items to resolution
• Drive site activities from start-up through close-out, including site selection, qualification, submissions, document collection, contracting, initiation, enrollment, monitoring, engagement, and close-out
• Monitor data quality, site compliance, adverse events, protocol deviations, and site communications
• Troubleshoot site and team issues and potentially implement CAPAs
• Drive project-level deliverables and maintain current, consistent project plans and TMF-level documents
• Ensure Trial Master File quality and audit readiness
• Assist with development, testing, and implementation of EDC, CTMS, TMF, and device-accountability systems
• Work with data management and biostatistics to develop reports and listings and review data trends
• Assist with clinical deliverables for regulatory submissions
• Develop clinical study reports
• Ensure compliance with contractual agreements, SOPs, ICH Guidelines, and applicable regulations
• Lead multidisciplinary clinical projects for simple to moderately complex studies
• Manage cross-functional groups
• Understand investigational products and the medical device development process
• Review monitoring reports
• Conduct and summarize literature searches
• Assist with clinical audits, regulatory inspections, and sponsor/vendor audits
• Organize and manage Investigator Meetings
• Select and manage Core Laboratories
• Select and manage safety committees such as DSMB or CEC

Clinical Study Manager

Director

• Provide scientific oversight and guidance for regional anatomic pathology evaluations
• Review study protocols, proposals, and pathology study designs
• Support clients and regulatory agencies with pathology expertise for study interpretation, regulatory submissions, and scientific consultations
• Ensure pathology assessments comply with GLP, OECD, FDA, ISO, and other applicable standards
• Maintain consistency, quality, and accuracy of pathology diagnoses across pathologists and sites
• Perform pathology evaluations, microscopic examinations, slide reviews, peer reviews, and consultations
• Lead regional pathology operations and optimize workflows, productivity, turnaround times, quality, and client satisfaction
• Establish and monitor departmental metrics, KPIs, and operational dashboards
• Collaborate with histology, necropsy, study directors, quality assurance, and laboratory operations teams
• Support new pathology methodologies, technologies, and service offerings
• Plan staffing and resources for current and future business demands
• Directly manage and develop US pathologists and pathology staff
• Lead recruitment, hiring, onboarding, retention, performance management, succession planning, and career development
• Assign workloads and monitor resource allocation
• Develop pathology training and competency assessment programs
• Coordinate peer review and diagnostic quality initiatives
• Support audits, regulatory inspections, client audits, and corrective actions
• Partner with senior leadership on departmental goals, growth strategies, and operational plans
• Participate in business development, client interactions, proposal development, conferences, professional societies, and industry meetings
• Serve as study pathologist for compliant nonclinical studies
• Develop protocol pathology methodologies and complete timely, accurate pathology reports
• Collaborate with facility veterinarians on diagnostic pathology data and colony health objectives
• Participate in necropsies and train associates in necropsy activities
• Provide technical guidance to histologists and train personnel in gross pathology and histology procedures
• Maintain GLP-compliant workspace and perform calibration and validation activities
• Assist research on techniques for identifying and interpreting pathological conditions

Clinical Study Manager

Associate Director – Regional Pathology