Study Start-up Lead

Roche UK

Prague, Czech Republic
On-site
Clinical trial start-up
Regulatory submissions
Ich-gcp
Roche UK is seeking a Study Start-up Lead to manage the initiation of clinical trials in Prague, focusing on efficient study start-up processes and regulatory compliance. The ideal candidate will possess a background in life sciences, experience in clinical trial start-up, and strong communication skills

Job Summary

  • As a member of the PDG Country Study Start-Up Team, your primary focus is to drive and facilitate efficient study start-up processes to contribute to the delivery of clinical trials (CT) to patients.
  • This role focuses on the efficient and compliant initiation of Roche-sponsored clinical trials by developing and implementing effective start-up strategies, overseeing start-up operations, and driving process improvements at the country and site level while maintaining regulatory compliance.
  • Roche encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.

Matching Summary

Match Score: 85

Roche UK is seeking a Study Start-up Lead to manage the initiation of clinical trials in Prague, focusing on efficient study start-up processes and regulatory compliance. The ideal candidate will possess a background in life sciences, experience in clinical trial start-up, and strong communication skills.

Skills & Requirements

Must-have

  • clinical trial start-up
  • regulatory submissions
  • ICH-GCP
  • EU CTR
  • local regulatory environments
  • cross-functional collaboration
  • vendor/CRO relationships

Nice-to-have

  • process automation
  • standardization
  • innovation
  • external industry collaborations
  • matrixed and global teams

Key Requirements

  • Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent
  • Postgraduate degree or master’s degree highly desirable
  • Fluency in written and spoken English is mandatory
  • Fluency in written and spoken language(s) of the host country is mandatory

Work Rights

Not specified

Tailored Resume

Cover Letter