Documentation Specialist
Core
Manage and maintain clinical trial documentation systems (eTMF) ensuring compliance with GCP, ICH, and SOP guidelines.
Role type
Clinical trial documentation specialist
Builds
Trial Master Files (TMF) and associated documentation repositories
Domain
Clinical research / Clinical trials
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
eTMF management, document QC, document scanning and filing, TMF metrics reporting, audit support, study status tracking, document categorization, proofreading
Preferred skills
Order processing experience, clinical study documentation familiarity, clinical trial database experience, Microsoft Office proficiency
Technologies
eTMF systems, clinical trial electronic databases, Microsoft Office
Responsibilities
Support eTMF setup, maintenance, and closeout; Conduct quality checks and content reviews of eTMF documents; Generate TMF metrics and content reports; Scan, label, upload, and file documents; Assist with internal and external TMF audits; Maintain study status trackers; Support TMF archival activities.
Seniority
Junior to Mid-level, hands-on IC
