Archive Specialist, Data Management
Core
Manage final study archives and clinical trial documentation to ensure compliance and support global research programs.
Role type
Senior IC archive specialist (clinical data management)
Builds
Final study archive packages for sponsors and sites
Domain
Clinical research / Life sciences
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial documentation management, archive audit, document acquisition coordination, quality review, archive directory structuring, stakeholder communication, project management, regulatory compliance knowledge
Preferred skills
Document management systems experience, electronic trial master files familiarity, Microsoft Office proficiency, Adobe Acrobat usage
Technologies
Document management systems, electronic trial master files, archive repositories, Microsoft Office, Adobe Acrobat
Responsibilities
Identify, collect, verify, audit, and organize clinical trial documentation; Conduct initial archive audits and assess documentation completeness; Create and maintain study-specific archive documentation and templates; Build and manage complex archive directory structures; Coordinate document acquisition activities; Execute quality reviews of archive packages; Prepare, package, upload, and coordinate delivery of completed archives; Track archive shipments and coordinate delivery confirmations; Maintain archive metrics, dashboards, and milestone trackers; Support quarter-end archive planning activities; Train and support team members on archive processes.
Seniority
Mid-level, hands-on IC
