Study Start-Up Project Manager

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

Study Start-Up Project Manager - Client Dedicated

Locations: Maidenhead
Country: United Kingdom
Time type: Full time
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

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