Study Start-up Lead

Roche Holding AG

Not specified (assumed hybrid based on company culture and role nature).
Clinical trial start-up strategy execution
Regulatory submissions to health authorities
Ethics committee coordination
Roche is seeking a Study Start-up Lead to drive efficient clinical trial initiation processes within its PDG Country Study Start-Up Team. The role emphasizes collaboration with internal and external stakeholders to ensure regulatory compliance, timely site activation, and innovation in study start-up strategies

Job Summary

  • This role drives efficient study start-up processes to ensure timely clinical trial delivery for patients across various therapeutic areas.
  • The position requires leading country strategies for regulatory submissions, site documentation, and financial contract management while maintaining compliance with ICH-GCP and EU CTR.
  • Roche fosters a culture of personal expression and open dialogue where every voice matters in the mission to prevent, stop, and cure diseases.

Matching Summary

Match Score: 85

Roche is seeking a Study Start-up Lead to drive efficient clinical trial initiation processes within its PDG Country Study Start-Up Team. The role emphasizes collaboration with internal and external stakeholders to ensure regulatory compliance, timely site activation, and innovation in study start-up strategies.

Skills & Requirements

Must-have

  • Clinical trial start-up strategy execution
  • Regulatory submissions to Health Authorities
  • Ethics Committee coordination
  • Fair Market Value budgeting
  • Contract negotiation and management
  • Veeva Vault and CTIS proficiency

Nice-to-have

  • Process automation and standardization
  • Cross-functional leadership in matrixed teams
  • Innovation in clinical trial delivery
  • External industry collaboration experience
  • Strong interpersonal communication skills

Key Requirements

  • Degree in life sciences (MD, PhD, MA/MS, BA/BS)
  • Experience in clinical trial start-up and regulatory submissions
  • Fluency in English and host country language
  • Knowledge of local regulatory environments including IVDRs

Work Rights

Not specified

Tailored Resume

Cover Letter