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
At Fortrea, we're all about turning the "impossible" into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job - it's a journey of making the exceptional possible, every day.
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Study Start‑Up Project Manager – Client Dedicated in Maidenhead employer: FTMAI Fortrea Development Ltd
Fortrea is an exceptional employer that fosters a collaborative work environment, where teamwork and dedication to patient service are at the forefront. With a hybrid working model in London, employees benefit from flexibility while gaining invaluable experience in complex oncological trials, alongside opportunities for professional growth in regulatory and TMF expertise. Join us to be part of a mission-driven team that values your contributions and supports your career development.
Contact Details:
FTMAI Fortrea Development Ltd Recruitment Team
