Study Startup Lead (Tokyo or Osaka)
Core
Lead study startup processes for clinical projects in Japan, ensuring smooth activation from project start to site readiness.
Role type
Senior clinical operations lead (study startup)
Builds
Clinical trial projects in Japan
Domain
Clinical trials / Life sciences
Deliverable
client delivery
Required skills
Study startup process management, site identification and selection, study dossier preparation and submission, contract and budget negotiation, translation review, CTMS tracking, process improvement, team training and mentoring
Preferred skills
None stated
Technologies
CTMS
Responsibilities
Lead study startup activities with local project teams; Support site identification and selection; Develop and update startup and site activation timelines; Supervise preparation and submission of study dossiers to sites and authorities; Lead development and negotiation of site contracts and budgets; Review study-specific translations; Oversee site activation progress and escalate issues; Track startup events in CTMS; Coordinate process improvement initiatives; Train project teams and mentor department staff; Develop and update local startup manuals and guides
Seniority
Senior, hands-on IC with mentorship responsibilities
