Study Start‐Up Project Manager – Client Dedicated

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

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

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

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