FSP - Local Clinical Trial Manager -South Korea
Core
Manage local clinical trial operations in South Korea to deliver clean data from evaluable patients within contractual timelines and quality standards.
Role type
Local Clinical Trial Manager (low to moderate complexity)
Builds
Clinical deliverables (clean data) for pharmaceutical/biotech clients
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial management, ICH GCP compliance, resource management, financial acumen, regulatory submission coordination, team leadership, project tracking, document archiving
Preferred skills
Clinical Study Manager (CSM) responsibilities on small projects, Accompanied Field Visits (AFVs), bid defense preparation
Technologies
Outlook, Excel, Word, automated clinical systems
Responsibilities
Manage clinical operational and quality aspects of allocated studies; Develop clinical tools (Monitoring Plan, Guidelines) and contribute to Trial Master File; Coordinate start-up activities and ethics committee submissions; Monitor clinical trials and manage CRF collection/query resolution; Lead team meetings and implement standardized monitoring processes; Communicate with study sites on protocol and patient participation issues.
Seniority
Mid-Senior, hands-on IC