Clinical Data Manager, External Site Studies
Remote - USFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- 1-3 years
- Required Skills
- GCPMS OfficeData management
Requirements
- Bachelor degree in Business, Science or related field or a combination of education and relevant internal Celerion experience
- 1-3 years industry experience
- 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
- High attention to detail
- Excellent oral and written communication skills
- Excellent organizational skills
- Proficiency in MS office applications
Responsibilities
- Independently own assigned data management studies and deliverables from startup through database lock
- 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
- 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 (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
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