Jobs at Celerion

Oversee end-to-end clinical data management for external site studies from startup through database lock. Responsibilities include managing EDC databases, designing and reviewing CRFs, conducting UAT, creating study documents, cleaning and reconciling data, managing queries, training site and client teams, coordinating stakeholders, communicating with sponsors, and ensuring regulatory compliance and timely final data delivery.

Performs pharmacokinetic data analysis, PK and PD interpretation, quality control reviews, clinical report writing, regulatory filing preparation, and study documentation management. The scientist independently conducts PK analyses, supports client interactions, prepares internal presentations, and interprets statistical findings. The role requires collaboration with senior scientists and may involve nonlinear mixed-effects or physiologically based pharmacokinetic modeling.

Performs pharmacokinetic and pharmacodynamic data analyses, independently interprets PK and statistical results, conducts quality-control reviews, writes clinical reports, prepares regulatory submission files, maintains study documentation, and supports client interactions and internal presentations.

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.