Celerion · 8 hours ago
Clinical Data Manager
Lincoln, NE
Full-time
Hybrid
Entry Level
1+ years expCelerion is committed to swift, exceptional clinical research through translational medicine. The Clinical Data Manager is responsible for ensuring the integrity, accuracy, and consistency of clinical data, managing communication with sponsors, and overseeing data management activities throughout clinical trials.
Health CarePharmaceutical
Responsibilities
Oversight of all clinical data management activities for assigned studies in accordance with SOP’s and Procedure Guides
Primary Sponsor contact for data management processes on study
Responsible for regular communication of study progress with internal and external project team
Oversee CRFs from the creation of the blank CRF through delivery of final CRF to sponsor
Ensure database is set up per specifications and perform User Acceptance Testing (UAT) of clinical database
Coordinate creation of Data Management Plan, CRF Completion Guidelines, Data Validation Plan, and other study documents required per SOP and study needs
Manage clinical data cleaning and delivery activities up to and including database lock
Review clinical data to ensure accuracy, quality, and integrity of data
Generate, resolve, and track queries to address discrepant data identified during review
Perform third party data reconciliations
Coordinate data transfers (clinical data and vendor related data) with assigned Data Programmer and Sponsor contact
Proactively ensure on-time delivery of study deliverables through monitoring of study timeline commitments
Manage and appropriately handle/archive all CDM study materials (internally and sponsor specific)
Proactively assess project activities and identify issues and/or risk
Provide high level customer service to all internal and external clients
Perform Quality Control reviews on studies, as needed
Qualification
Required
High School Diploma or GED
Ability to manage multiple projects/priorities
High attention to detail
Excellent oral and written communication skills
Excellent organizational skills
Proficiency in MS office applications
Preferred
College degree strongly preferred
1-2 years industry experience preferred
Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred
Knowledge of SAS preferred
Company
Celerion
Celerion, a leader in early clinical research, delivers Applied Translational Medicine.
1001-5000 employees
H1B Sponsorship
Celerion has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (7)
2023 (5)
2022 (3)
2021 (6)
2020 (5)
Funding
Current Stage
Late StageTotal Funding
unknown2022-11-03Acquired
2010-01-01Seed
Leadership Team
Susan C. Thornton
President and CEO
JoAnne Rosal
Chief Financial Officer
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