Jobs at Celerion

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.

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.

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.

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.

Lead GLP/GxP-compliant bioanalytical studies and method validations as Study Director/Principal Investigator. Serve as primary client contact, oversee study planning through reporting, review analytical data for regulatory compliance, mentor laboratory staff, coordinate lab operations, and support process improvements and client-facing scientific activities.

Set up and maintain clinical trials in ClinQuick EDC. Create study conduct instruction manuals and detailed timed event schedules for clinic staff and participants. Manage logistical study setup and ensure accurate documentation in a fast-paced clinical research environment.

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.

Perform scheduled study events per protocol, collaborate with study managers, conduct vital signs, ECGs, blood draws and telemetry monitoring, identify and report adverse events, and document study activities. Work 4x10 shifts (05:00–17:00) with one weekend per month.

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.

Support development of bioanalytical study scopes, budgets, and pricing. Prepare proposals, RFQs, and contracts; monitor project financials, forecasting, invoicing, and WIP. Improve pricing tools and Smartsheet workflows, use AI/automation for efficiency, and assist with ordering study-specific materials.

Support development of scopes, budgets, and pricing for bioanalytical studies; prepare proposals, RFQs, and contracts; manage project financials, forecasting, invoicing, and close-out; optimize pricing tools and Smartsheet workflows and use automation to improve processes.

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.

Provide direct clinical support for research trials on evening shift: perform scheduled protocol events, vitals, ECGs, blood draws, telemetry, report adverse events, and coordinate with study managers to ensure trial success.

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.