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 internal and external stakeholders.
Role type
Senior Clinical Trial Manager (Country Level)
Builds
Clinical trial studies for innovative medicines
Domain
Life Sciences / Clinical Research
Required skills
GCP/ICH guidelines knowledge, clinical research process expertise, risk management, stakeholder coordination, regulatory submission management, data integrity management, vendor assessment, site feasibility planning, patient recruitment strategy, CAPA implementation
Preferred skills
Therapeutic area expertise, mentoring capabilities, cross-functional team leadership
Technologies
CTMS, eDC, eTMF, Microsoft Suite
Responsibilities
Implement local country and site feasibility processes, plan and execute study start-up timelines, manage patient recruitment and enrollment targets, lead problem-solving and risk mitigation efforts, verify and confirm eTMF completeness, prepare investigator sites for trials, coordinate database locks and query follow-up, ensure inspection readiness, manage Corrective and Preventive Actions (CAPA), coordinate study team meetings, support regulatory submissions to Health Authorities and Ethics Committees, manage site relationships and closure activities.
Seniority
Senior, hands-on IC