[Remote] Clinical Data Manager, External Site Studies
Note: The job is a remote job and is open to candidates in USA. Celerion is committed to swift, exceptional clinical research through translational medicine. In this role, you will provide expert oversight of end-to-end data management for external site clinical trials, ensuring data integrity and regulatory compliance while collaborating with various teams and managing project timelines.
Responsibilities
- 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
Skills
- 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
- 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
- Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred
- Knowledge of SAS and Veeva EDC preferred
Company Overview
Company H1B Sponsorship