Senior Specialist, Country Study Start Up
Core
Proactively drives and executes all start-up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries.
Role type
Senior Specialist, Country Study Start Up (Clinical Research)
Builds
Site activation plans, document packages, clinical supply shipments, and site activation in IXRS
Domain
Clinical Research / Pharmaceutical
Required skills
Clinical research regulations interpretation, IRB/EC review and ICF customization, clinical supply management, site activation in IXRS, process improvement, change management, data analysis, risk assessment, stakeholder collaboration
Preferred skills
Study start-up management, mentoring junior personnel, working with remote/virtual teams, knowledge of ICH and GCP guidelines
Technologies
Vault SSU, IXRS
Responsibilities
Execute start-up and maintenance activities for assigned sites and studies; Coordinate with Regulatory and CTS on CA submission and approval status; Trigger clinical supply shipments and complete IP release activities; Maintain local country and site intelligence database and EDLs; Mentor junior personnel on Vault and drive change management; Drive process improvement initiatives to improve site start-up efficiency.
Seniority
Senior, hands-on IC
