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.
Are you looking for an opportunity to support a business creating life-saving treatments? If so, we can't wait to meet you!
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
Excellent organizational skills required
Proficiency in MS office applications required
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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.
