Clinical Trial Manager
Core
End-to-end operational oversight and delivery of clinical trials at a country level, ensuring adherence to timelines, budget, and quality standards while coordinating with global and local stakeholders.
Role type
Senior Clinical Trial Manager (Country Level)
Builds
Country-level clinical study execution and regulatory compliance
Domain
Life Sciences / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GCP and ICH Guidelines expertise, clinical research process knowledge, risk management, stakeholder coordination, regulatory submission management, data management in CTMS/eTMF, vendor assessment, site feasibility planning, patient recruitment strategy, CAPA implementation
Preferred skills
Therapeutic area subject matter expertise, mentoring capabilities, cross-functional team leadership
Technologies
CTMS, eDC, eTMF, Microsoft Suite
Responsibilities
Coordinate country-level study start-up, feasibility, and site initiation; manage patient recruitment and enrollment targets; oversee regulatory submissions to Health Authorities and Ethics Committees; ensure inspection readiness and manage CAPA; coordinate database locks and query follow-ups; manage vendor relationships and site closure activities.
Seniority
Senior, hands-on IC
