Celerion

Global CRO for early-phase development

Clinical Data Manager - External Site Studies

Clinical Research OperationsUpdated on Nov 10

Full-timeRemote in USANo salary listedRemote

About the Job

Requirements

A bachelor's degree in Business, Science, or a related field is required, or a combination of education and relevant internal Celerion experience may be accepted in lieu.
At least 1 year of industry experience is required.
Ability to manage multiple projects and priorities is required.
High attention to detail is required.
Excellent oral and written communication skills are required.
Excellent organizational skills are required.
Proficiency in Microsoft Office applications is required.

Responsibilities

Deliver comprehensive data-management services across all study phases.
Independently own assigned data-management studies and deliverables from startup through database lock, proactively identifying risks, resolving issues, communicating status, and escalating when appropriate.
Ensure clinical databases are complete, accurate, and compliant with sponsor and regulatory standards.
Serve as the primary sponsor contact for data-management activities.
Lead data-management communications and coordinate with internal and external teams to ensure timely delivery of study milestones and progress updates.
Train site staff, including CRCs, CRAs, and PIs, and client teams on EDC systems.
Oversee the CRF lifecycle from design to final delivery.
Conduct user acceptance testing and ensure database setup aligns with specifications.
Develop and manage essential study documents, including the Data Management Plan, CRF Completion Guidelines, Validation Plans, and SAE Reconciliation Plans.
Review and clean clinical data, manage queries, and reconcile third-party data.
Coordinate database lock and final data delivery.
Identify risks and proactively resolve project issues.
Provide service to internal and external stakeholders.

Desired Qualifications

Knowledge of Good Clinical Data Management Practices, medical terminology, GCP, ICH Guidelines, and 21 CFR Part 11 is preferred.
Knowledge of SAS and Veeva EDC is preferred.

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

Essential Functions:

Deliver comprehensive data management services across all study phases
Independently own assigned data management studies and deliverables from startup through database lock, proactively identifying risks, resolving issues, communicating status, and escalating when appropriate
Ensure clinical databases are complete, accurate, and compliant with Sponsor and regulatory standards
Serve as primary Sponsor contact for data management activities
Lead data management communications and coordinate with internal and external teams to ensure timely delivery of study milestones and progress updates
Train site staff (CRCs, CRAs, PIs) and client teams on EDC systems
Oversee CRF lifecycle from design to final delivery
Conduct User Acceptance Testing (UAT) and ensure database setup aligns with specifications
Develop and manage essential study documents (e.g., Data Management Plan, CRF Completion Guidelines, Validation Plans, SAE Reconciliation Plans)
Review and clean clinical data, manage queries, and reconcile third-party data
Coordinate database lock and final data delivery
Identify risks and proactively resolve project issues
Provide exceptional service to internal and external stakeholders

Qualifications:

Bachelor degree in Business, Science or related field or a combination of education and relevant internal Celerion experience in lieu required
1-3 years industry experience required
Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred
Knowledge of SAS and Veeva EDC preferred
Ability to manage multiple projects/priorities required
High attention to detail required
Excellent oral and written communication skills required
Excellent organizational skills required
Proficiency in MS office applications required

#LI-Remote

Celerion Values: Integrity Trust Teamwork Respect

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

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About the Company

Celerion

Global CRO for early-phase development

Celerion is a global contract research organization focused on early-phase drug development. It conducts contracted research across clinical trial design, feasibility studies, project management, clinical and medical monitoring, bioanalytical sciences, and regulatory affairs, using High Resolution Mass Spectrometry-based metabolite profiling to inform decisions. Its advantage comes from over 40 years of experience, specialized metabolite profiling, and a global, integrated service model that accelerates development timelines. The goal is to help pharmaceutical and biotech clients bring safe and effective treatments to patients faster through rigorous, high-quality research.

Company size: 1,001-5,000
Company stage: Acquired
Total funding: Not listed
Headquarters: Lincoln, NE
Founded: 2010

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