Clinical Data Manager, External Site Studies

Celerion conducts clinical research using translational medicine and innovative research strategies to accelerate drug development. The Clinical Data Manager, External Site Studies provides end-to-end oversight of clinical data management for external site trials, ensuring data integrity, regulatory compliance, and timely delivery of high-quality datasets. The role manages study deliverables, coordinates internal and external stakeholders, communicates with Sponsors, and oversees data cleaning, testing, documentation, and database lock activities.

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 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

Preferred

Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred

Knowledge of SAS and Veeva EDC preferred

Clinical Data Management

Medical Terminology

GCP

ICH Guidelines

21 CFR Part 11

SAS

Veeva EDC

Benefits

This Full-Time role is 100% remote.

Company

Early-phase clinical research and bioanalytical services for drug development

Lincoln, Nebraska, USA

https://celerion.com/

Founded in 2010

1001-5000 employees

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

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

Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred

Knowledge of SAS and Veeva EDC preferred

Required skills

Clinical Data Management, Clinical Data Management Practices, Medical Terminology, Clinical Practice (GCP), ICH Guidelines, 21 CFR Part 11, SAS, Veeva EDC, Microsoft Office

Preferred skills

Knowledge of SAS and Veeva EDC preferred

Experience

1-3 years