Clinical Trial Coordinator II (m/f/d)
Core
Provides administrative and technical support to clinical trial project teams, ensuring audit readiness and managing study documentation.
Role type
Clinical Trial Coordinator (Administrative & Technical Support)
Builds
Clinical trial documentation, regulatory submissions, and study metrics reports
Domain
Clinical Research / Life Sciences
Deliverable
Dashboards & analysis | client delivery
Required skills
Study documentation management, regulatory document review, data analysis and reconciliation, vendor tracker maintenance, meeting coordination, translation support
Preferred skills
Knowledge of ICH GCP and country regulations, clinical trial database systems proficiency, MS Office advanced skills
Technologies
GoBalto, eTMF, clinical trial database systems
Responsibilities
Perform department, internal, country, and investigator file reviews; ensure allocated tasks are performed on time and within budget; maintain study-specific documentation and systems; process documents for client (e)TMF; analyze and reconcile study metrics; assist with Investigator Site File (ISF) and pharmacy binder materials distribution
Seniority
Individual Contributor, mid-level
