（Associate) Country Study Manager - Onco
Core
Lead the end-to-end delivery of clinical studies in a specific country, managing local study teams, investigators, and regulatory submissions to ensure timely, compliant, and high-quality data delivery.
Role type
Senior Clinical Study Manager (Country Level)
Builds
Clinical study operations and regulatory submissions for oncology trials
Domain
Life Sciences / Clinical Research / Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study management, local study team leadership, investigator relations, regulatory submission coordination, budget and timeline forecasting, audit and inspection preparation, risk management, training and mentoring
Preferred skills
Experience with targeted monitoring, knowledge of local regulatory environments, ability to facilitate document translation
Technologies
IMPACT, ACCORD
Responsibilities
Form and lead local study teams (monitors and administrators), coordinate investigator selection and recruitment strategies, manage study budgets and timelines, prepare country-level study master files and regulatory applications, conduct or coordinate monitoring visits and audits, ensure compliance with ICH-GCP and local regulations, facilitate document translation, and report study progress to senior management.
Seniority
Senior, hands-on IC
