Client-Dedicated Study Start-Up Lead

Fortrea; Maidenhead; Hybrid; GBP 65,000 - 90,000; Full time

Job summary

Fortrea is seeking a Study Start-Up Project Manager to lead country-level regulatory submissions, approvals and site readiness for a global, client-dedicated program. The role involves coordination across internal teams, external authorities, and vendors, with a hybrid work model requiring 2-3 days in London.

The ideal candidate has 5+ years in clinical research with strong start-up/regulatory exposure and a solid understanding of local regulatory environments.

Qualifications

• 5+ years' experience in clinical research with regulatory exposure.
• Solid knowledge of local regulatory environments and approval processes.
• Ability to work independently, manage multiple protocols, and mitigate regulatory risk.
• Strong stakeholder-management and influencing skills.
• Bachelor's degree in Life Sciences, Healthcare, Business, or related field.

Responsibilities

• Oversee end-to-end regulatory submissions and approvals per ICH-GCP and local regulations.
• Interact with IRB/IEC and Regulatory Authorities, including amendments and approvals.
• Develop and oversee local regulatory documentation (ICFs, translations).
• Ensure regulatory compliance, timelines and country commitments during start-up and close-out.

Skills

Regulatory submissions

Stakeholder management

Regulatory risk mitigation

Education

Bachelor's degree in Life Sciences, Healthcare, Business, or related field

Job description

Fortrea is seeking a Study Start-Up Project Manager to lead country-level regulatory submissions, approvals and site readiness for a global, client-dedicated program. The role involves coordination across internal teams, external authorities, and vendors, with a hybrid work model requiring 2-3 days in London.

The ideal candidate has 5+ years in clinical research with strong start-up/regulatory exposure and a solid understanding of local regulatory environments.