Study Start Up Lead (ssul)

Roche

Not specified; not specified; not specified
Leading country start-up strategy
Managing icf preparation and submission
Overseeing clinical trial regulatory submissions
This role focuses on the efficient and compliant initiation of Roche-sponsored clinical trials by developing effective start-up strategies

Job Summary

  • This role focuses on the efficient and compliant initiation of Roche-sponsored clinical trials by developing effective start-up strategies.
  • The position requires leading teams in strategy development, proactive risk mitigation, and managing regulatory coordination for study amendments.
  • Roche offers a culture that encourages personal expression, open dialogue, and genuine connections where every voice matters.

Matching Summary

This role focuses on the efficient and compliant initiation of Roche-sponsored clinical trials by developing effective start-up strategies.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • Leading country start-up strategy
  • Managing ICF preparation and submission
  • Overseeing clinical trial regulatory submissions
  • Ensuring compliance with ICH-GCP and EU CTR
  • Negotiating site budgets and contracts
  • Fluency in English and host country language

Nice-to-have

  • Experience with Veeva Vault and CTIS systems
  • Strong cross-functional collaboration skills
  • Ability to lead through complexity
  • Process automation and innovation mindset
  • External industry collaboration experience

Key Requirements

  • Degree in life sciences or equivalent
  • Postgraduate degree highly desirable
  • Demonstrated experience in clinical trial start-up
  • Proven leadership or line management experience
  • Mandatory fluency in host country language

Work Rights

Not specified

Tailored Resume

Cover Letter