12 дней назад
RWE - Site Mgr 2 (Clinical Research)
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
RWE - Site Mgr 2 (Clinical Research): Conducting remote and occasional on-site clinical study monitoring in São Paulo, ensuring investigator sites follow protocols, GCP, regulations, and sponsor requirements with an accent on site start-up, regulatory documentation, data quality, and issue resolution. Focus on reviewing electronic case report form data, resolving data queries, coordinating site activities with CRAs and clinical operations teams, and supporting studies through database lock.
Location: São Paulo, Brazil; remote monitoring with on-site visits when needed
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Conduct remote initiation, monitoring, and close-out visits in accordance with study protocols, GCP, SOPs, regulations, and contracted scope of work.
- Perform site identification, selection, start-up, regulatory submissions, ethics approvals, and site contract and budget activities as needed.
- Manage communication with investigator sites, provide site training and support, and coordinate with field CRAs, Clinical Operations Leads, project management, regulatory start-up, and epidemiology teams.
- Review electronic case report form data, ensure timely data transmission, resolve queries, and support final data review through database lock.
- Maintain site documentation, visit reports, tracking systems, essential documents, and study records.
- Escalate site risks and performance issues, support site payments and audits, and assist less experienced clinical staff when needed.
Requirements
- Bachelor’s degree preferred, ideally in a scientific or healthcare discipline, or an equivalent combination of education, training, and experience.
- At least 2 years of relevant clinical experience preferred.
- Intermediate knowledge of clinical research processes, medical terminology, study designs, ICH, GCP, and applicable regulations.
- Good command of English, with strong written and verbal communication skills.
- Ability to manage multiple priorities, meet deadlines, work independently, apply critical thinking, and maintain effective professional relationships.
- Proficiency with electronic data capture, basic data processing, Microsoft Word, and Microsoft Excel.
Culture & Benefits
- Full-time employment within a global clinical research organization.
- Collaborative work with clinical operations, regulatory, epidemiology, project management, and field CRA teams.
- Work is primarily remote for site monitoring, with on-site monitoring or co-monitoring when required.
- Work is performed according to documented protocols, SOPs, GCP, and applicable regulations.
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