Specialist, Country Study Start Up
Core
Proactively drives and executes all start-up and maintenance activities and deliverables for assigned clinical studies and sites in a specific country.
Role type
Specialist, Country Study Start Up (SSU)
Builds
Site activation plans, ethics packages, clinical supply shipments, and site activation in IXRS.
Domain
Clinical research / Pharmaceutical
Required skills
Study start-up management, risk assessment and mitigation, regulatory compliance (ICH/GCP), clinical supply coordination, database management, KPI tracking, audit readiness, process improvement, team training and mentorship
Preferred skills
Bachelor's degree in health care or scientific field, experience with remote/virtual teams
Technologies
IXRS, Vault SSU, ALCOA
Responsibilities
Establish country/site activation plans and priorities; compile and submit ethics and local document packages; coordinate with Regulatory and CTS on CA submission; trigger clinical supply shipments and complete IP release; maintain local country and site intelligence database; maintain SSU performance metrics and KPIs; ensure compliance with corporate policies and worldwide regulations; participate in process improvement initiatives; train and mentor new Specialists.
Seniority
Individual Contributor, Specialist level
