Specialist, Country Study Start Up
Core
Proactively drives and executes all start-up and maintenance related activities and deliverables for assigned clinical studies and sites in a specific country.
Role type
Specialist, Country Study Start Up
Builds
Site activation and study maintenance for clinical trials
Domain
Clinical research / Pharmaceutical
Deliverable
client delivery
Required skills
Study start-up management, risk assessment and mitigation, regulatory document compilation, clinical supply coordination, site activation tracking, local country intelligence management, KPI tracking, audit readiness, ICH/GCP guidelines knowledge, country regulatory environment understanding
Preferred skills
Healthcare or scientific degree, remote/virtual team collaboration, process improvement, mentoring
Technologies
IXRS, Vault SSU, ALCOA
Responsibilities
Ensure successful and on-time execution of start-up and maintenance activities for assigned sites and studies; Compile and submit ethics and local document packages including customization of ICFs; 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; Maintain SSU performance metrics and KPIs for assigned sites/studies
Seniority
Specialist, individual contributor
