Senior Specialist, Country Study Start Up
Core
Proactively drives and executes start-up and maintenance activities for assigned clinical studies and sites in a specific country, ensuring on-time, budget, and quality delivery.
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
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical research study start-up management, regional clinical research regulations interpretation, IRB/EC interaction and ICF review, clinical supply chain coordination, regulatory compliance (ICH/GCP), data management in Vault SSU, process improvement leadership, mentoring and training.
Preferred skills
Bachelor's degree in health care or scientific field, experience with remote/virtual teams, analytical and critical thinking skills.
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; trigger clinical supply shipments and complete IP release; maintain local country and site intelligence database; mentor junior personnel on tools and processes; drive process improvement initiatives to enhance site start-up efficiency.
Seniority
Senior, hands-on IC
