Regulatory Study Start-Up Lead - Hybrid London

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

Benefits offered by this job

Hybrid work model

Job summary

Fortrea in London is seeking a Study Start-Up PM to lead country‑level submissions, approvals and site readiness for a global client‑dedicated program. The role focuses on regulatory leadership across ICH‑GCP and local UK requirements, with 2–3 days onsite in London.

You will manage IRB/IEC interactions, develop local regulatory documents, ensure timelines, coordinate with CRM, CRA, Finance and Legal, and mentor junior staff.

Qualifications

• 5+ years in clinical research with strong study start-up/regulatory exposure.
• Solid knowledge of local regulatory environments and approval processes.
• Ability to 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

• Oversight of end‑to‑end regulatory submissions and approvals per ICH‑GCP and local rules.
• IRB/IEC and Regulatory Authority interactions, incl. amendments and approvals.
• Development and oversight of local regulatory documentation (ICFs, translations).
• Accountability for regulatory compliance, timelines, and country commitments.
• Coordinate with CRM, CTC, CRA, Finance and Legal to deliver submissions and CTRAs.
• Collaborate with Headquarters to align country timelines.
• Oversee site readiness, local vendors, and country processes.
• Manage clinical and ancillary supplies, import/export, archiving, retention, insurance.
• Maintain country data in clinical and finance systems.
• Act as regulatory SME, support process improvement and mentoring.

Skills

Regulatory submissions

Study Start-Up

Stakeholder management

Independent work

Education

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

Job description

Fortrea in London is seeking a Study Start-Up PM to lead country‑level submissions, approvals and site readiness for a global client‑dedicated program. The role focuses on regulatory leadership across ICH‑GCP and local UK requirements, with 2–3 days onsite in London.

You will manage IRB/IEC interactions, develop local regulatory documents, ensure timelines, coordinate with CRM, CRA, Finance and Legal, and mentor junior staff.