Study Start‑Up Project Manager – Client Dedicated

📍 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.