Study Start‑Up Project Manager – Client Dedicated

📍London | 2–3 days onsite (hybrid)

Are you aregulatory‑focused Study Start‑Up expert who thrives on ownership and compliance? We’re looking for aStudy Start‑Up PM to leadcountry‑level submissions, approvals and site readiness for a global, client‑dedicated program.

What you’ll own

• Oversight of end‑to‑endregulatory submissions and approvals in line withICH‑GCP, UK/local regulations, and internal quality standards
• IRB/IEC and Regulatory Authority interactions, including amendments and approvals
• Development and oversight oflocal regulatory documentation (ICFs, translations)
• Accountability forregulatory compliance, timelines, and country commitments during start‑up and close‑out
• Coordination withCRM, CTC, CRA, Finance, and Legal to deliver submissions, budgets, CTRAs, and local milestones
• Close collaboration withHeadquarters to align country timelines
• Oversight ofsite readiness, local vendors, and country‑level processes
• Management ofclinical and ancillary supplies, import/export, archiving, retention, and insurance processes
• Maintenance ofcountry data in clinical and finance systems
• Acting as aregulatory SME, supporting process improvement, best‑practice sharing, and mentoring
   

What we’re looking for

• 5+ years’ experience in clinical research with strongstudy start‑up/regulatory exposure
• Solid knowledge oflocal 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 inLife 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 ourEEO & Accommodations request here.