Clinical Trial Manager
Core
End-to-end study operational oversight and delivery at country level, ensuring adherence to timelines, budget, and quality standards for clinical trials.
Role type
Senior IC Clinical Trial Manager
Builds
Clinical trials for innovative medicines
Domain
Life Sciences / Clinical Research
Required skills
GCP/ICH guidelines knowledge, clinical research process expertise, risk mitigation, stakeholder coordination, regulatory submission management, data management (CTMS/eTMF), vendor management, site feasibility planning, patient recruitment strategy
Preferred skills
Therapeutic area expertise, mentoring capabilities, cross-functional team leadership
Technologies
Microsoft Suite, CTMS, eDC, eTMF
Responsibilities
Coordinate country-level study start-up and site feasibility; implement patient recruitment strategies; manage risk and issue resolution; ensure data completeness in CTMS/eTMF; prepare and validate study documents; coordinate regulatory submissions to Health Authorities and Ethics Committees; manage vendor relationships; support inspection readiness and CAPA implementation.
Seniority
Senior, hands-on IC