обновлено 13 дней назад
Senior Site Startup Associate
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Site Startup Associate (Clinical Trials/Regulatory): Managing clinical trial site start-up activities in Argentina, including regulatory submissions, essential document review, informed consent adaptation, and site contract and budget negotiations with an accent on country-specific compliance and study activation timelines. Focus on forecasting approvals, resolving start-up issues, and coordinating sponsors, investigators, ethics committees, and project stakeholders.
Location: Argentina
Company
supports biotech, medtech, and specialty pharmaceutical companies in developing medicines, devices, and diagnostics through clinical research services.
What you will do
- Forecast submission and approval timelines, monitor adherence, develop contingency plans, and escalate delays.
- Prepare and submit ongoing submissions, amendments, and end-of-study notifications to ethics committees, institutional review boards, and local authorities.
- Collect and review essential documents to ensure sponsor and investigator obligations comply with local regulations and ICH/GCP guidelines.
- Prepare, negotiate, and finalize site-specific contracts and budgets with investigators, sponsors, and contracts stakeholders.
- Review and adapt informed consent forms, patient documents, and other country-specific study documentation.
- Support the development of study start-up strategies during proposal and business development stages.
Requirements
- Undergraduate degree or international equivalent in a clinical, science, or health-related field, or a licensed healthcare qualification.
- At least 5 years of direct clinical study start-up experience.
- Thorough knowledge of FDA guidance documents, EU directives and regulations, local regulations, ISO 14155, drug and device development, and clinical monitoring procedures.
- Strong knowledge of country-specific clinical trial regulations and site and institution contract requirements.
- Expertise in developing and reviewing informed consent templates and other patient-facing study documents.
- Strong verbal and written English communication skills required.
Culture & Benefits
- Flexible working practices designed to support work-life balance.
- Opportunities to develop skills and advance professionally.
- Collaborative environment where team members’ ideas and perspectives influence ways of working.
- Opportunity to contribute to medical innovation and clinical research.
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