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Information Technology • Consulting
Manages procurement, qualification, validation, maintenance, troubleshooting, and documentation for laboratory measurement and test equipment. Develops protocols, reports, SOPs, risk assessments, and change controls; investigates failures and nonconformances; supports electronic data compliance, building expansion validations, engineering systems, audits, training, and equipment monitoring. Partners with laboratories and IT to maintain compliant, reliable testing operations.
Information Technology • Consulting
Provides regional scientific and operational leadership for anatomic pathology evaluations supporting nonclinical medical device studies. Reviews protocols, pathology data, and reports; ensures GLP, FDA, OECD, ISO, and other regulatory compliance; manages pathologists and pathology staff; oversees quality, peer review, training, staffing, and resource allocation; improves workflows and service offerings; supports audits, regulatory submissions, client consultations, business development, and scientific representation.
Information Technology • Consulting
Manages clinical research studies involving site monitoring, human subject protection, GCP and regulatory compliance. Coordinates site qualification, initiation, interim and close-out visits; maintains study documents and metrics; supports audits, submissions, safety activities, data management, protocol development and trial registration. Serves as a liaison among investigative sites, clients and study teams, and provides training and mentoring to CRAs. Travel may range from 20% for in-house roles to 80% for field roles.
Information Technology • Consulting
Manages clinical research studies involving site monitoring, human subject protection, GCP and regulatory compliance. Coordinates site qualification, initiation, interim and close-out visits; oversees study documentation, metrics, training, audits, budgets, safety activities and regulatory submissions. Supports protocol development, data management, core laboratory operations, literature reviews and trial registration. Mentors CRAs and communicates study performance, risks and progress to investigators, clients and internal teams.