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Clinical Data Manager – External Site Studies
Location
United States
Posted
1 day ago
Salary
0
Seniority
Junior
Job Description
Clinical Data Manager – External Site Studies
Celerion
• 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
Job Requirements
- 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
Benefits
- Celerion Values: Integrity Trust Teamwork Respect
- Equal Opportunity Employer
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