9 дней назад
Senior Clinical Data Manager
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Data Manager (Clinical Data Management): Leading end-to-end clinical data management projects from study setup through database lock and close-out with an accent on EDC selection, data validation, regulatory compliance, and client coordination. Focus on designing study documentation, overseeing UAT and external data integration, resolving complex data issues, and mentoring clinical data managers.
Location: Remote within Argentina; Buenos Aires, Argentina
Company
is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data and regulatory submission services.
What you will do
- Lead the full clinical data management process from study setup through study close-out.
- Advise clients on best-fit EDC solutions and coordinate directly with EDC and IWR suppliers.
- Oversee CRF tracking and data entry, external data integration, data validation, query resolution, coding, SAE reconciliation, database lock, and database QC audits.
- Develop and oversee CRFs, CRF Completion Guidelines, annotated CRFs, validation specifications, Data Management Plans, and study tracking reports.
- Lead user acceptance testing and collaborate with cross-functional teams to deliver study timelines.
- Mentor clinical data managers, support proposals and bid defense meetings, and contribute to SOP and process improvements.
Requirements
- Bachelor’s or Master’s degree in a scientific or healthcare field, or relevant industry experience.
- 5+ years of experience in clinical data management, including at least 1 year leading projects.
- Extensive knowledge of paper CRF, EDC, and hybrid clinical data management systems.
- Extensive knowledge of Clinical Operations SOPs and working practices.
- Strong understanding of GCP, ICH guidelines, and applicable FDA regulations.
- Excellent verbal and written communication, interpersonal, organizational, and independent problem-solving skills.
Culture & Benefits
- Full-time employment with remote work from Argentina.
- Collaborative and inclusive work environment.
- Opportunities to expand knowledge of drug development and clinical research.
- Work with pharmaceutical, biotech, and medical device organizations across a global CRO.
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