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
Learn more about our EEO & Accommodations request here.
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Study Start-Up Project Manager in Maidenhead employer: Fortrea
Fortrea is an exceptional employer that offers a rewarding and meaningful work environment, particularly for Senior Technical Designers. With a strong support network, flexible working solutions, and a commitment to employee growth, you will thrive in a collaborative workspace that values diversity and inclusion. Enjoy competitive compensation packages and the opportunity to make a significant global impact while maintaining a genuine work-life balance.
