Study Start Up Lead (ssul)

Roche UK

United Kingdom
On-site
Study start-up strategy
Regulatory compliance
Site activation
Roche UK is seeking a Study Start Up Lead (SSUL) to oversee the initiation of clinical trials, ensuring regulatory compliance and efficient site activation. The ideal candidate will have experience in clinical trial start-up, regulatory submissions, and strong leadership skills in a collaborative environment

Job Summary

  • 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.
  • You will lead in a cross functional environment in multiple of the following areas below: Study Start-Up Strategy & Execution, Informed Consent Form (ICF) Management, Clinical Trial Submissions & Regulatory Coordination, Site Documentation & Compliance, Budgeting & Contract Management, Payment Oversight.
  • At Roche you can show up as yourself, embraced for the unique qualities you bring.

Matching Summary

Match Score: 85

Roche UK is seeking a Study Start Up Lead (SSUL) to oversee the initiation of clinical trials, ensuring regulatory compliance and efficient site activation. The ideal candidate will have experience in clinical trial start-up, regulatory submissions, and strong leadership skills in a collaborative environment.

Skills & Requirements

Must-have

  • Study start-up strategy
  • Regulatory compliance
  • Site activation
  • ICH-GCP
  • EU CTR
  • Clinical systems proficiency

Nice-to-have

  • Process automation
  • Cross-functional leadership
  • Global team collaboration
  • Adaptable mindset

Key Requirements

  • Degree in life sciences or equivalent
  • Demonstrated experience in clinical trial start-up
  • Experience managing vendor/CRO relationships
  • Proven leadership or line management experience

Work Rights

Not specified

Tailored Resume

Cover Letter