· Preparation of new studies %28sites/CROs selection, core-documents writing, training materials, work processes with all parties involved, submission for study approval, sites initiations%29
· Ongoing study management, including:
o Sites management / pts FU %28protocol compliance, problems solving%29
o Core labs and service provider%27s management
o Monitors management
o Support of the EDC operation, data management and queries
o Safety management %28review of AEs, reporting per regulations, support CEC & DSMB processes%29
o Study Insurance
o Budget / payments
· Conduct periodic site visits %28engagement and management%29
· Administrative clinical department support
· Assist with other department’s needs %28regulatory, R&D, QA%29
Qualifications
ü 6+ years of experience in a medical device industry with at least 4 + years Clinical Affairs
ü B.Sc. in life science, medical science
ü Strong knowledge of GCP and other regulatory requirements
ü Excellent written and oral English communication skills, including proficiency in scientific/medical terminology
ü Good organizational abilities
ü Experience with working with physicians abroad
ü Overseas travel 20%
ü High presentation and interpersonal skills
