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 ownOversight of end to end regulatory submissions and approvals in line with ICH GCP, UK/local regulations, and internal quality standardsIRB/IEC and Regulatory Authority interactions, including amendments and approvalsDevelopment and oversight of local regulatory documentation (ICFs, translations)Accountability for regulatory compliance, timelines, and country commitments during start up and close outCoordination with CRM, CTC, CRA, Finance, and Legal to deliver submissions, budgets, CTRAs, and local milestonesClose collaboration with Headquarters to align country timelinesOversight of site readiness , local vendors, and country level processesManagement of clinical and ancillary supplies , import/export, archiving, retention, and insurance processesMaintenance of country data in clinical and finance systemsActing as a regulatory SME , supporting process improvement, best practice sharing, and mentoringWhat we're looking for5+ years' experience in clinical research with strong study start up/regulatory exposureSolid knowledge of local regulatory environments and approval processesAbility to work independently, manage multiple protocols, and mitigate regulatory riskStrong stakeholder management and influencing skillsBachelor's degree in Life Sciences, Healthcare, Business, or related fieldWhy this role?High impact regulatory leadership at the most critical study phaseClient dedicated model with real ownership and visibilityHybrid working model with 2-3 days per week in LondonLearn more about our EEO & Accommodations request here .