Senior Clinical Trial Manager
Core
End-to-end operational oversight and delivery of clinical trials at the 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
Clinical trial operations and patient enrollment for innovative medicines
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 mitigation, stakeholder coordination, regulatory submission management, CAPA implementation, site relationship management
Preferred skills
Therapeutic area subject matter expertise, mentoring capabilities, Health Authority inspection readiness
Technologies
CTMS, eDC, eTMF, Microsoft Suite
Responsibilities
Implement country and site feasibility processes, execute study start-up timelines, manage patient recruitment strategies, lead risk resolution and issue escalation, verify eTMF completeness, prepare investigator sites and documentation, coordinate database locks and query follow-up, ensure inspection readiness, manage CAPA for audit findings, coordinate regulatory submissions to Health Authorities and Ethics Committees, support site closure activities
Seniority
Senior, hands-on IC
