Clinical Data Manager, External Site Studies

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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