Senior SSUA/Site Start Up Associate II

Location: United Kingdom

Company

hirify.global supports biotech, medtech, and specialty pharma companies in developing medicines, medical devices, and diagnostics.

What you will do

• Manage quality country-level deliverables for clinical study start-up in line with project requirements and local regulations.
• Forecast submission and approval timelines, create contingency plans for delays, and escalate risks.
• Prepare and submit Central EC/IRB, Local EC, regulatory authority, and hospital approval applications.
• Prepare ongoing submissions, amendments, periodic notifications, safety reports, and end-of-study notifications.
• Collect and review essential documents for compliance with sponsor, investigator, local regulatory, and ICH/GCP requirements.
• Prepare, submit, and negotiate investigator contracts and site budgets where applicable.

Requirements

• Undergraduate degree or international equivalent in a clinical, science, or health-related field, or qualification as a licensed healthcare professional.
• For the senior level, proven SSUA II experience and/or 7+ years of related experience, including at least 5 years submitting clinical trial applications.
• Experience with interventional IMP, non-interventional, medical device, GMO, and observational studies.
• Experience leading larger programs through study start-up.
• Working knowledge of FDA guidance documents, EU directives and regulations, local regulations, ISO 14155, drug and device development, and clinical monitoring procedures.

Culture & Benefits

• Part-time contract position with a 0.5 FTE workload.
• Six-month contract duration.
• Hourly compensation.
• Flexible working approach designed to support work-life balance and professional growth.