About the role
📍 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 .