Trial Delivery Specialist - Clinical Trial Coordinator
Core
Coordinate and facilitate clinical trial activities, serving as a cross-functional liaison and study lead to support project teams and ensure trials are completed on time, within budget, and to high quality standards.
Role type
Clinical Trial Coordinator (Central or Local)
Builds
Clinical trial documentation, regulatory submissions, and study metrics reports for pharmaceutical and biotech clients.
Domain
Clinical Research / Pharmaceutical Trials
Required skills
Project coordination, regulatory document review, (e)TMF management, data analysis, vendor tracking, meeting organization, translation support, MS Office proficiency, GCP knowledge
Preferred skills
Bachelor's degree, 4+ years of relevant experience, PPD clinical training completion
Technologies
GoBalto, eTMF, clinical trial database systems, MS Office
Responsibilities
Coordinate assigned trial activities per task matrix; perform department, internal, country, and investigator file reviews; ensure tasks are completed on time and within budget; maintain study documentation and (e)TMF; support RBM activities; process documents for client submission; track local regulatory documents; transmit documents to client and IRB/IEC; analyze and reconcile study metrics; assist with ISF and pharmacy binder compilation; support study-specific translation materials.
Seniority
Mid-level, hands-on IC
