Study Start-up Lead

Roche UK

Lead study start-up strategy execution
Manage clinical trial regulatory submissions
Oversee site documentation and compliance
This role drives efficient study start-up processes to ensure timely delivery of clinical trials to patients across various therapeutic areas

Job Summary

  • This role drives efficient study start-up processes to ensure timely delivery of clinical trials to patients across various therapeutic areas.
  • The position requires leading the country strategy for study start-up while maintaining strict regulatory compliance with local Health Authorities and Ethics Committees.
  • 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

This role drives efficient study start-up processes to ensure timely delivery of clinical trials to patients across various therapeutic areas.

Skills & Requirements

Must-have

  • Lead study start-up strategy execution
  • Manage clinical trial regulatory submissions
  • Oversee site documentation and compliance
  • Handle budgeting and contract management
  • 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 and ambiguity
  • Knowledge of EU CTR and ICH-GCP guidelines
  • Innovative mindset for process automation

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter