Start Up Lead APAC
Core
Lead global site start-up activities for clinical trials in the APAC region, ensuring timely activation and regulatory compliance.
Role type
Senior Site Start-Up Lead (Clinical Operations)
Builds
Activated clinical trial sites and regulatory submissions
Domain
Clinical Research / Life Sciences / Oncology
Required skills
Site start-up strategy, IRB/EC & CA/MoH submissions, ICF customization, IMP release package delivery, cross-functional coordination, risk mitigation, milestone tracking, translation coordination, training & mentoring, client presentation
Preferred skills
None stated
Technologies
Milestone tracking tools, electronic spreadsheets, word processing, email systems
Responsibilities
Develop activation readiness strategies, coordinate critical path planning, collaborate with stakeholders for milestone alignment, participate in client meetings, partner with functional leaders to mitigate risks, oversee tracking systems, coordinate document translations, maintain communication with key functions, act as SME for local regulations, support country-specific process development, facilitate training sessions, mentor staff on local regulations, interact with clients in proposal activities