Study Start‑Up Project Manager – Client Dedicated

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

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 Own

• Oversight of end‑to‑end regulatory submissions and approvals in line with ICH‑GCP, UK/local regulations, and internal quality standards
• IRB/IEC and Regulatory Authority interactions, including amendments and approvals
• Development and oversight of local regulatory documentation (ICFs, translations)
• Accountability for regulatory compliance, timelines, and country commitments during start‑up and close‑out
• Coordination with CRM, CTC, CRA, Finance, and Legal to deliver submissions, budgets, CTRAs, and local milestones
• Close collaboration with Headquarters to align country timelines
• Oversight of site readiness, local vendors, and country‑level processes
• Management of clinical and ancillary supplies, import/export, archiving, retention, and insurance processes
• Maintenance of country data in clinical and finance systems
• Acting as a regulatory SME, supporting process improvement, best‑practice sharing, and mentoring

What We’re Looking For

• 5+ years’ experience in clinical research with strong study start‑up/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

Why this role?

• High‑impact regulatory leadership at the most critical study phase
• Client‑dedicated model with real ownership and visibility
• Hybrid working model with 2–3 days per week in London

Learn more about our EEO & Accommodations request here.