Study StartUp Project Manager – Client Dedicated

Maidenhead - UK

Monthly Salary: Not Disclosed

Posted on: 22 hours ago

Vacancies: 1 Vacancy

Job Summary

London 23 days onsite (hybrid)

Are you a regulatoryfocused Study StartUp expert who thrives on ownership and compliance Were looking for a Study StartUp PM to lead countrylevel submissions approvals and site readiness for a global clientdedicated program.

What youll own

Oversight of endtoend regulatory submissions and approvals in line with ICHGCP 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 startup and closeout
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 countrylevel 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 bestpractice sharing and mentoring

What were looking for

5 years experience in clinical research with strong study startup/regulatory exposure
Solid knowledge of local regulatory environments and approval processes
Ability to work independently manage multiple protocols and mitigate regulatory risk
Strong stakeholdermanagement and influencing skills
Bachelors degree in Life Sciences Healthcare Business or related field

Why this role

Highimpact regulatory leadership at the most critical study phase
Clientdedicated model with real ownership and visibility
Hybrid working model with 23 days per week in London

Learn more about our EEO & Accommodations request here.

Required Experience:

London 23 days onsite (hybrid)Are you a regulatoryfocused Study StartUp expert who thrives on ownership and compliance Were looking for a Study StartUp PM to lead countrylevel submissions approvals and site readiness for a global clientdedicated program.What youll ownOversight of endtoend regulato...