Systeembeheer
Core
Administrative support for clinical trials, ensuring accurate Trial Master File delivery and site compliance tracking.
Role type
Senior Clinical Trial Assistant (CTA)
Builds
Clinical Trial Master Files (TMF) and clinical documentation
Domain
Clinical research / Pharmaceutical
Deliverable
client delivery
Required skills
Clinical trial operations, TMF management, clinical data flow coordination, regulatory compliance (GCP/ICH), study file review, team mentorship
Preferred skills
Site visit accompaniment, process improvement initiatives
Technologies
Microsoft Word, Excel, PowerPoint
Responsibilities
Update and maintain clinical documents and systems (e.g., Trial Master File), prepare and archive clinical documentation, coordinate Case Report Forms (CRFs) and queries, act as central contact for project communications, mentor less experienced CTAs, assist with training and onboarding, accompany CRAs on site visits
Seniority
Mid-level, hands-on IC with mentorship duties