Lead country-level regulatory submissions, approvals and site readiness for a client-dedicated global program. Manage IRB/IEC and regulatory authority interactions, local documentation, compliance, timelines, vendors, supplies, and cross-functional coordination to ensure study start-up and close-out deliverables.
📍 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
- 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
- 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.
Top Skills
Crm,Clinical Systems,Finance Systems
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