📍 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
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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.
