Study Start-Up Project Manager – Client Dedicated

• 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

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.

• 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

📍 London | 2-3 days onsite (hybrid)