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Clinical Data Manager, External Site Studies

2 months, 3 weeks ago
United States
Full-time
Junior
Database Administrator
Database Administration
GCP
Apply Now
Celerion

Celerion

Celerion is a pioneer in early clinical research, offering Applied Translational Medicine services worldwide to expedite drug development processes.

Pharmaceuticals
251-1K
Founded 2010
View All Jobs 7

Description

  • Provide end-to-end data management oversight across all phases of external site clinical studies.
  • Independently own assigned studies and deliverables from startup through database lock.
  • Serve as the primary sponsor contact for data management activities.
  • Lead data management communications and coordinate with internal and external teams to support study milestones and status updates.
  • Train site staff and client teams on EDC systems.
  • Oversee the CRF lifecycle from design through final delivery.
  • Conduct user acceptance testing and ensure database setup aligns with study specifications.
  • Develop and maintain study documents such as Data Management Plans, CRF Completion Guidelines, Validation Plans, and SAE Reconciliation Plans.
  • Review and clean clinical data, manage queries, and reconcile third-party data.
  • Coordinate database lock and final data delivery while identifying, resolving, and escalating project risks and issues.

Requirements

  • Bachelor’s degree in Business, Science, or a related field, or equivalent education and relevant Celerion experience.
  • 1-3 years of industry experience.
  • Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part 11 preferred.
  • Knowledge of SAS and Veeva EDC preferred.
  • Ability to manage multiple projects and priorities.
  • High attention to detail.
  • Excellent oral and written communication skills.
  • Excellent organizational skills.
  • Proficiency in MS Office applications.

Benefits

  • 100% remote work in the US.
  • Full-time position.
  • Opportunity to support the development of life-saving treatments.
  • Equal opportunity employer consideration for all qualified applicants.

Interested in this position?

Apply directly on the company website

Apply Now

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