Start Up Lead
Core
Lead global site start-up activities, managing strategy, planning, and coordination to ensure timely clinical trial activation.
Role type
Senior Clinical Operations Lead (Site Start-Up)
Builds
Site activation readiness and on-time study start-up
Domain
Clinical Research / Life Sciences
Required skills
Site start-up strategy, critical path planning, stakeholder management, risk mitigation, milestone tracking, translation coordination, regulatory submission knowledge (IRB/EC/CA/MoH), IMP release management, training and mentoring
Preferred skills
Advanced degree in life sciences, CRO or pharma/biotech experience, project management experience, GCP/ICH guidelines knowledge
Technologies
Milestone tracking tools, electronic spreadsheets, word processing, email systems
Responsibilities
Develop activation readiness strategies, coordinate IRB/EC and contract execution, collaborate with stakeholders for milestone planning, present client expectations, identify and mitigate delivery risks, oversee tracking systems, coordinate document translations, develop country-specific process flows, facilitate training sessions, mentor staff on regulations, interact with clients in proposal activities
Seniority
Senior, hands-on IC with leadership responsibilities