Study ‑Up Project Manager – Client Dedicated

Position: 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 standardsIRB/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 for5+ 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 .