Clin Ops Delivery Associate III
Core
Senior Clinical Trial Coordinator providing administrative and technical support for clinical trial activities across pharmaceutical and biotech projects.
Role type
Senior Clinical Trial Coordinator
Builds
Clinical trial documentation, regulatory submissions, and study metrics reports
Domain
Clinical Research / Pharmaceutical
Deliverable
client delivery
Required skills
Clinical trial database systems, (e)TMF management, regulatory document review, study metrics analysis, vendor tracker maintenance, ISF/Pharmacy binder coordination, translation QC
Preferred skills
Bachelor's degree, 4+ years of relevant experience
Technologies
GoBalto, eTMF, MS Office (Word, Excel, PowerPoint)
Responsibilities
Coordinate and oversee assigned trial activities per task matrix; perform department, internal, country, and investigator file reviews; ensure tasks are completed on time, within budget, and to high quality standards; maintain study-specific documentation and global support systems; support RBM activities; process documents for client (e)TMF; schedule and organize client/internal meetings; review and track local regulatory documents; transmit documents to client and centralized IRB/IEC; analyze and reconcile study metrics; maintain vendor trackers; assist with coordination of Investigator Site File and Pharmacy binder materials.
Seniority
Senior, hands-on IC
