Jobs at Celerion

Conducts statistical analyses for clinical research projects using SAS, develops statistical analysis plans, creates randomization schedules, prepares tables and reports, interprets data, and oversees analysis execution. The role also involves coordinating with sponsors and internal departments, reviewing reports, supporting programming, and communicating timelines and deliverables.

Conduct statistical analyses for clinical research studies using SAS. Responsibilities include developing statistical analysis plans, generating randomization schedules, preparing tables, figures, listings, and reports, interpreting data, supporting database transmissions, reviewing deliverables, assisting with programming, and coordinating with internal teams and clients.

Lead national business development for biologics, biomarkers, molecular and cellular bioanalysis services. Acquire new biotechnology and pharmaceutical clients, build opportunity pipelines, develop scientific and commercial relationships, lead proposals and negotiations, and support growth of bioanalytical laboratories. Provide technical expertise in advanced assay technologies and emerging therapeutic modalities while collaborating with scientific, operational, marketing, and regional business development teams.

Manages preparation, review, negotiation, execution, and tracking of client and subcontractor agreements for clinical research projects. Coordinates legal review and works with Finance, Operations, Business Development, sponsors, subcontractors, and other stakeholders. Develops change orders, payment schedules, and cash flow analyses while assessing contractual business risk and supporting high-volume contract activity.

Manages Quality Control and Data Entry workflows for clinical studies, including staff supervision, workload planning, regulatory compliance, sponsor and auditor communication, SOP development, metrics tracking, data review, and process improvement. Ensures accurate, timely, and compliant clinical data processing while leading problem solving, inspections, audits, and employee development.

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.

Perform scheduled clinical trial procedures under study protocols, including vital signs, ECGs, blood draws, telemetry monitoring, participant care, documentation, and adverse-event reporting. Collaborate with study managers to support successful overnight trials involving healthy participants. The role requires a current Nebraska RN or LPN license, clinical assessment skills, and strong computer and documentation abilities. ACLS certification is preferred. Overnight shifts run approximately 7 p.m. to 7:30 a.m., including one weekend per month.

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.

Convert R&D bioanalytical assay workflows into robust, documented robotic routines; program and validate liquid-handling methods using VENUS and EVOware on Hamilton robots; monitor robot performance; support automated workflows in a regulated lab; and balance development with operational support to improve throughput and reliability.

Responsible for subject safety and executing IRB-approved clinical trial protocols per FDA and GCP. Duties include pre-study review, consenting and screening subjects, conducting exams, managing and reporting adverse events/SAEs, reviewing CRFs and study data, coordinating with sponsors and IRB, designing study procedures, maintaining physician networks, and supporting SOPs, training, and emergency response.

Develop and validate ligand-binding immunoassays (ELISA, MSD, etc.) for PK/PD/biomarkers and ADA, analyze and troubleshoot data, lead method development projects, support regulatory-compliant studies, collaborate cross-functionally, author scientific communications, and engage with clients.

Provide on-site IT desktop, server, and network support for the Zurich site, acting as primary IT contact. Handle IMAC activities, endpoint deployment/imaging (Intune, SCCM/MECM, Autopilot), Active Directory and Windows Server tasks, Citrix and Oracle client support, basic SQL/ODBC configuration, local cabling and switch troubleshooting, ticket resolution, backups/restores, and ensure compliance with GxP and change-control procedures. Deliver onboarding and end-user training and coordinate with global IT teams for escalations.

Lead technical conduct of small-molecule bioanalytical studies: serve as primary client contact, review protocols and sample analysis plans, approve reports and QA audits, oversee training, manage deviations and investigations, and ensure data integrity.

Support participant activities for clinical studies: screen and register participants, maintain study records and databases, collect and organize paperwork, communicate with panelists, and coordinate travel between Lincoln and Omaha sites. Work Monday–Friday with emphasis on organization and participant relations.