Sr/Site Start up Associate II

Location: Regional Australia

Company

hirify.global supports biotech, medtech, and specialty pharma organizations in developing medicines, medical devices, and diagnostics through clinical research services.

What you will do

• Manage country-level study start-up deliverables, timelines, submission forecasts, escalations, and contingency planning.
• Prepare and submit Central and Local EC/IRB, regulatory authority, hospital, amendment, safety, and end-of-study applications.
• Collect, review, translate, and quality-check essential documents and Trial Master File records in line with the File Management Plan.
• Prepare and negotiate site-specific contracts and budgets with investigators, sites, sponsors, and Contracts Leads.
• Identify and engage clinical trial sites, support pre-award assessments, and provide country-level regulatory and site start-up intelligence.
• Act as a primary liaison for site start-up issues while maintaining tracking systems, regulatory repositories, and study status information.

Requirements

• Undergraduate degree or international equivalent in a clinical, science, or health-related field, or qualification as a licensed healthcare professional.
• Experience as an SSUA I and/or at least two years of experience submitting clinical trial applications.
• Experience with interventional IMP, non-interventional, medical device, GMO, and observational studies.
• Strong knowledge of ICH/GCP, ISO 14155, applicable local regulations, regulatory authority requirements, drug and device development, and clinical monitoring procedures.
• Detailed knowledge of country-specific clinical trial requirements, health systems, cultural practices, and site and institution contract requirements.
• Proficiency in developing and reviewing informed consent forms, patient documents, and other country-specific documentation.

Nice to have

• Experience with pediatric, complex, or neuroscience studies, including epilepsy.
• Experience leading larger programs through study start-up.
• Additional relevant experience for consideration at a more senior level.

Culture & Benefits

• Flexible working practices designed to support professional growth and work-life balance.
• Opportunities to influence working methods and contribute ideas.
• Exposure to life-changing clinical research across medicines, devices, and diagnostics.
• Coaching, mentoring, supervision, and training opportunities within the SSUA role.