Bachelor's degree in Business, Science, or related field, or equivalent experience
1-3 years of industry experience
Knowledge of Good Clinical Data Management Practices
Familiarity with SAS and Veeva EDC preferred
Strong project management skills
Excellent attention to detail and communication skills
Proficiency in MS Office applications
Responsibilities
Deliver comprehensive data management for clinical trials
Ensure clinical databases meet compliance and accuracy standards
Act as primary Sponsor contact for data management
Lead communications and coordinate study progress updates
Train site staff and client teams on EDC systems
Oversee the CRF lifecycle from design to delivery
Review and clean clinical data, managing queries and reconciliations
Benefits
100% remote work opportunity
Commitment to integrity, teamwork, and respect in company culture
Focus on delivering life-saving treatments through clinical research
Opportunity to work directly with Sponsors and health professionals
Engagement in end-to-end data management across clinical study phases
Full Job Description
This Full-Time role is 100% remote.
As a Clinical Data Manager - External Site Studies, you will provide expert oversight of end-to-end data management for external site clinical trials, ensuring data integrity, regulatory compliance, and timely delivery of high-quality datasets using Celerion's or Sponsor-provided EDC systems. This role involves cross-functional collaboration, direct Sponsor communication, and active management of project timelines, while also leveraging various database systems and software tools to efficiently manage, organize, and clean clinical data throughout the study lifecycle.
This role is ideal for a proactive data management professional who demonstrates strong ownership of assigned studies, sound judgment in day-to-day decision-making, effective prioritization across multiple deliverables, and the ability to escalate issues appropriately.
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
