This role provides operational oversight of assigned clinical trial protocols at the country level from start-up through database lock and closeout
Job Summary
This role provides operational oversight of assigned clinical trial protocols at the country level from start-up through database lock and closeout.
The incumbent ensures the local trial team delivers quality data compliant with ICH-GCP, company SOPs, and regulatory requirements while managing recruitment targets within budget.
Key responsibilities include acting as the primary company contact, driving study compliance via CAPA, and ensuring inspection readiness for all trial documents.
Matching Summary
This role provides operational oversight of assigned clinical trial protocols at the country level from start-up through database lock and closeout.
Salary
Not specified; Not specified; Not specified
Skills & Requirements
Must-have
ICH-GCP regulatory knowledge
local trial management experience
site feasibility and selection
budget forecasting and control
investigator meeting coordination
CAPA implementation
informed consent document management
Nice-to-have
early phase trial experience
therapeutic area expertise
vendor selection skills
process improvement initiatives
strong communication skills
willingness to travel occasionally
Key Requirements
BA/BS degree in health or science field
2 years of local trial management experience
Proficiency in country language and English
Strong working knowledge of ICH-GCP and local laws