CTC/Sr CTC - FSP
Core
Senior Clinical Trial Coordinator providing administrative and technical support to project teams in Oncology/Cell therapy clinical trials.
Role type
Senior Clinical Trial Coordinator (Study Lead)
Builds
Clinical trial operations and documentation for pharmaceutical and biotech clients
Domain
Clinical Research / Oncology / Cell Therapy
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, meeting coordination
Preferred skills
Bachelor's degree, 4+ years of relevant experience, PPD clinical training completion
Technologies
GoBalto, eTMF, MS Office
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; track local regulatory documents; transmit documents to client and IRB/IEC; analyze and reconcile study metrics; assist with Investigator Site File and Pharmacy binder materials; support study-specific translation materials and QC.
Seniority
Senior, hands-on IC