9 дней назад
Senior Clinical Data Manager (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Data Manager (Clinical Research): Leading end-to-end clinical data management for studies from setup through close-out with an accent on EDC strategy, database design, data validation, regulatory compliance, and client collaboration. Focus on integrating external data, resolving complex data issues, overseeing UAT and database lock activities, and mentoring clinical data managers.
Location: Remote within Brazil; São Paulo, Brazil
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 close-out.
- Advise clients on best-fit EDC solutions and manage relationships with EDC and IWR suppliers.
- Review protocols and oversee the development of CRFs, completion guidelines, annotated CRFs, validation specifications, and data management plans.
- Oversee CRF tracking, data entry, external data integration, validation, query resolution, coding, SAE reconciliation, database lock, and QC audits.
- Manage UAT, study tracking, metrics, timelines, and cross-functional project coordination.
- Support capabilities and bid defense meetings, improve SOPs and processes, and mentor new clinical data managers.
Requirements
- Bachelor’s or Master’s degree in a scientific or healthcare field is preferred, together with relevant industry experience.
- At least 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 verbal, written, interpersonal, and organizational communication skills.
- Must be remotely based within Brazil.
Culture & Benefits
- Full-time employment within a supportive and collaborative organization.
- Remote work arrangement within Brazil.
- Opportunity to contribute to clinical research projects across pharmaceutical, biotech, and medical device industries.
- Work in a Great Place to Work certified organization with a focus on employee development and innovation.
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