Associate Start-up Team Manager
Core
Develops and manages the critical path for site activation within assigned projects to provide consultation, guidance, and support for rapid site activations.
Role type
Associate Site Activation Specialist
Builds
Site activation critical paths and regulatory compliance review packages
Domain
Life Sciences / Clinical Trials / Regulatory Affairs
Deliverable
client delivery
Required skills
Site activation strategy, regulatory compliance, local submission strategy, SOP adherence, database management, process improvement, technical expertise, country-specific documentation
Preferred skills
Mentoring junior staff, cross-functional collaboration, country process improvement
Technologies
Database systems, office software
Responsibilities
Achieve project target cycle times for site activations, act as country subject matter expert, develop and implement local submission strategy, prepare regulatory compliance review packages, liaise locally for submission planning, develop country-specific documents, coordinate internal departments for site startup alignment, maintain accurate trial status information in database, participate in country process improvement initiatives
Seniority
Associate, hands-on IC