Clinical Data Specialist

Celerion conducts clinical research to support the development of drugs. The Clinical Data Specialist reviews source data, ensures accurate and complete entry into databases and Case Report Forms, and supports clinical trial setup, conduct, and data cleaning.

Responsibilities

• Attend study setup meetings to determine QC criteria and timelines for each study
• Review study-specific source documents to ensure all forms are accurate prior to study start and that all data collected is in accordance with study-specific Case Report Forms and protocol requirements
• Ensure QC reviews are complete in accordance with study-specific timelines
• Review source data on an ongoing basis to ensure the following: Clinical source data is complete according to GCP and FDA guidelines, protocol deviations (if applicable) are documented, and source data is collected in accordance with Sponsor requirements, and Celerion SOPs/PGs. Ensure data corrections are completed according to GCP guidelines, and Celerion SOPs/PGs. Complete a Final QC to ensure all source data is accounted for and has been QC reviewed
• Perform accurate data entry and verification for Celerion Standard and Sponsor Provided EDCs
• Archive source documentation including CRFs
• Complete QC/DE dedicated milestones in a timely manner
• Perform standard quality control steps

Preferred

• relevant internal Celerion experience in lieu preferred
• 1 - 2 years industry experience preferred
• Previous Quality Control/ Data Entry or related experience preferred
• Medical Terminology Training preferred
• Celerion Experience
• Industry Experience
• Quality Control
• Data Entry
• Medical Terminology Training

Company

• Early-phase clinical research and bioanalytical services for drug development
• Lincoln, Nebraska, USA
• https://celerion.com/
• Founded in 2010
• 1001-5000 employees

Qualifications

• High School Diploma or GED
• Excellent oral and written communication skills
• Ability to organize and manage multiple priorities
• Experience working in an environment with complex processes and defined criteria
• Excellent time management skills required
• Proficient in MS Office applications required
• Excellent attention to detail skills required
• Relevant internal Celerion experience in lieu preferred
• 1 - 2 years industry experience preferred
• Previous Quality Control/ Data Entry or related experience preferred
• Medical Terminology Training preferred

Required skills

• Data Entry, Quality Control

Preferred skills

• (3), (4), (5), (6), (7), *2026, 1 - 2 years industry experience preferred, 2020, 2021, 2022, 2023, 2024, 2025, 3.5, 91, Customer Service and Support, Data Powered by, Distribution of Different Job Fields Receiving Sponsorship, Engineering and Development, Glassdoor, H1B Sponsorship, Late Stage, Lincoln, Nebraska, USA, Management and Executive, Medical Terminology Training preferred, Represents job field similar to this job, Total Funding, Trends of Total Sponsorships, https://celerion.com/, relevant internal Celerion experience in lieu preferred

Experience

• 1-2 years