Clinical Operations Lead (Tokyo or Osaka)
Core
Lead line management and mentoring of Clinical Research Associates (Monitors) for site selection, initiation, monitoring, and closeout visits in clinical trials.
Role type
Senior Clinical Operations Lead (Mentor)
Builds
Clinical trial operations and monitor performance
Domain
Clinical Research / Contract Research Organization (CRO)
Deliverable
client delivery
Required skills
CRA mentoring, site visit planning, quality control, data integrity, investigational product handling, resource allocation
Preferred skills
MS Office proficiency, dynamic team environment adaptation
Technologies
MS Office
Responsibilities
Prepare, conduct, and report site selection, initiation, routine monitoring, and closeout visits; Mentor Monitors on project-specific activities and support their professional development; Plan and conduct supervised monitoring visits with training and assessment; Build and maintain relationships with site staff; Contribute to performance appraisals of monitors; Train and coach the Clinical Operations team; Supervise Site Management Associates regarding document and supply flow; Ensure quality control, data integrity, and compliance; Manage Investigational Products and clinical study supplies; Support resource allocation and staff utilization.
Seniority
Senior, hands-on IC with mentorship focus