Study Start‑Up Project Manager – Client Dedicated

Fortrea; Thatcham; Hybrid; GBP 80,000 - 120,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Fortrea in London seeks a regulatory-focused Study Start-Up Project Manager to lead country-level submissions, approvals and site readiness for a global client-dedicated program.

You will oversee end-to-end regulatory submissions, IRB/IEC interactions, and local documentation, while coordinating with cross-functional teams to meet timelines and budget. This hybrid role offers ownership and visibility in a high-impact area.

Qualifications

• 5+ years in clinical research with study start-up/regulatory exposure.
• Strong knowledge of local regulatory environments and approvals.
• Ability to manage multiple protocols and mitigate regulatory risk.
• Excellent stakeholder management and influencing skills.

Responsibilities

• Lead country-level regulatory submissions and approvals.
• Oversee site readiness, vendors, and country processes.
• Coordinate with CRM, CTC, CRA, Finance, and Legal on submissions and budgets.
• Mentor and share best practices across regions.

Skills

Regulatory experience

Stakeholder management

Independence

Risk mitigation

IRB/IEC interactions

Education

Bachelor’s degree in Life Sciences

Job description

London | 2–3 days onsite (hybrid)Are you a regulatory‑focused Study Start‑Up expert who thrives on ownership and compliance? We’re looking for a Study Start‑Up PM to lead country‑level submissions, approvals and site readiness for a global, client‑dedicated program.What you’ll ownOversight of end‑to‑end regulatory submissions and approvals in line with ICH‑GCP, UK/local regulations, and internal quality standardsIRB/IEC and Regulatory Authority interactions, including amendments and approvalsDevelopment and oversight of local regulatory documentation (ICFs, translations)Accountability for regulatory compliance, timelines, and country commitments during start‑up and close‑outCoordination with CRM, CTC, CRA, Finance, and Legal to deliver submissions, budgets, CTRAs, and local milestonesClose collaboration with Headquarters to align country timelinesOversight of site readiness , local vendors, and country‑level processesManagement of clinical and ancillary supplies , import/export, archiving, retention, and insurance processesMaintenance of country data in clinical and finance systemsActing as a regulatory SME , supporting process improvement, best‑practice sharing, and mentoringWhat we’re looking for5+ years’ experience in clinical research with strong study start‑up/regulatory exposureSolid knowledge of local regulatory environments and approval processesAbility to work independently, manage multiple protocols, and mitigate regulatory riskStrong stakeholder‑management and influencing skillsBachelor’s degree in Life Sciences, Healthcare, Business, or related fieldWhy this role?High‑impact regulatory leadership at the most critical study phaseClient‑dedicated model with real ownership and visibilityHybrid working model with 2–3 days per week in LondonLearn more about our EEO & Accommodations request here .