Study Start Up Associate Director

apartmentNovartis placeBarcelona calendar_month 

Experteer Overview

In this role, you drive end-to-end Study Start-Up performance across a global, highly matrixed portfolio. You lead a cross-functional SSU team to balance speed, quality, and risk, ensuring timely readiness for site activation and enrollment. You influence senior stakeholders, shape ways of working, and support continuous improvement in TMF readiness and global vendor collaboration.

Your work enables faster study start-up while maintaining regulatory compliance and inspection readiness. This is a strategic, enterprise-minded leadership position with scope to mentor others and contribute to growth and transformation.

Compensaciones / Beneficios
  • Own SSU activities for medium to highly complex studies
  • Make independent decisions on SSU activities
  • Ensure global trial-level document readiness and eTMF collection for submissions and site activation
  • Guide Trial Vendor Manager to ensure timely vendor activation and submission documents
  • Ensure transparency of SSU timelines and country alignment
  • Maintain TMF document accuracy and inspection readiness in SSU
  • Oversee risk management to meet start-up timelines and quality
  • Coach country SSU Managers to drive timely start-up from allocation to Ready to Enroll
  • May serve as SSU Director deputy to lead SSU community and mentor team members
Responsabilidades
  • Advanced degree or Bachelor’s degree with equivalent experience
  • Minimum 6 years in project management or clinical operations overseeing trials
  • Minimum 3 years contributing to global/ matrix clinical trials
  • Proven ability to lead associates across dispersed, matrixed organizations
  • Experience leading multidisciplinary teams in a complex matrix environment
  • Demonstrated leadership in driving high-performing teams with stakeholder management
  • Good knowledge of Good Clinical Practice, trial setup design, and global drug development process
Requisitos principales

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