Celerion
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Pharmaceutical
Leads and manages Clinical Research Associates while overseeing monitoring and site management for clinical trials. Responsibilities include staff hiring, training, coaching, workload allocation, performance management, monitoring plan execution, CTMS oversight, sponsor communication, audit and inspection support, regulatory compliance, issue resolution, and quality improvement. The role may also conduct site visits and requires experience with feasibility, qualification, initiation, monitoring, closeout, investigational product accountability, Trial Master Files, and serious adverse event handling.
Pharmaceutical
Build and administer EDC trials including eCRF design and EDC builds, program edit checks, create test data and environments, execute UAT coordination, program reports/listings with Veeva CDB, manage secure data imports, validate system upgrades, and maintain CDISC database standards.
