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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