25 дней назад
Senior Clinical Data Manager (Remote - Colombia)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Data Manager (Remote - Colombia) (Clinical Research): Leading end-to-end clinical data management for studies, from setup through close-out, with an accent on EDC selection, database design, data validation, and regulatory compliance. Focus on coordinating suppliers and clients, resolving complex data issues, overseeing UAT and database lock activities, and mentoring clinical data managers.
Location: Remote within any location in Colombia
Company
is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device industries with clinical trial data and regulatory submission expertise.
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.
- Oversee CRF tracking, data entry, external data integration, validation, query resolution, coding, SAE reconciliation, database lock, and QC audits.
- Develop and oversee CRFs, CRF Completion Guidelines, annotated CRFs, validation specifications, and Data Management Plans.
- Coordinate client, supplier, and cross-functional activities to meet study timelines.
- Lead UAT, contribute to process improvements and SOP updates, and mentor new clinical data managers.
Requirements
- Bachelor’s or Master’s degree in a scientific or health care field, or 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.
- Excellent verbal and written communication, interpersonal, and organizational skills.
- CV must be submitted in English.
Culture & Benefits
- Full-time remote employment within Colombia.
- Supportive, collaborative, and inclusive work environment.
- Opportunity to work on complex clinical research and regulatory submission challenges.
- Professional development through mentoring, training, and exposure to drug development projects.
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