Start-up Team Manager – EMEA Clinical Trial Start-Up Lead - FSP
Core
Lead operational delivery of complex clinical trial start-up activities across multiple EU countries, ensuring site activation, regulatory compliance, and project timelines.
Role type
Senior IC clinical trial start-up manager (EMEA)
Builds
Clinical studies for pharmaceutical/biotech clients
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Required skills
EU-CTR regulatory knowledge, multi-country start-up leadership, cross-functional coordination, risk management, project management, budget control, stakeholder management, clinical development understanding
Preferred skills
Experience with national/local committee approvals outside EU-CTR, cross-cultural communication, fast-paced environment adaptability
Technologies
PPD/Thermo Fisher Scientific tools and processes
Responsibilities
Lead and oversee start-up activities across multiple EU countries; Navigate EU-CTR requirements alongside country-specific regulations; Coordinate feasibility, site contracts, and country teams; Monitor and analyze project status providing metrics to senior management; Manage financial and contractual aspects of site activation; Establish controls to ensure resources align with budgets.
Seniority
Senior, hands-on IC