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4 дня назад

Senior Clinical Data Manager (Remote - Mexico)

Формат работы
remote (только Mexico)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Mexico
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Senior Clinical Data Manager (Remote - Mexico) (Clinical Data Management): Managing clinical trial data from study setup through close-out, including EDC selection, database design, validation, query resolution, and database lock with an accent on regulatory compliance, data quality, and client coordination. Focus on leading data management projects, integrating external clinical data, overseeing UAT and QC activities, and resolving complex study-processing issues independently.

Location: Remote within Mexico; the posting lists Mexico City, Mexico.

Company

hirify.global 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

  • Manage clinical data activities from study setup through close-out and serve as the primary contact for study-specific data management issues.
  • Advise clients on EDC solutions and coordinate directly with EDC and IWR suppliers.
  • Oversee CRF tracking and data entry, external data integration, validation, query resolution, adverse event and medication coding, SAE reconciliation, database lock, and QC audits.
  • Develop and oversee CRFs, CRF completion guidelines, annotated CRFs, validation specifications, and data management plans.
  • Lead user acceptance testing, prepare study metrics and tracking reports, and coordinate timelines with cross-functional teams.
  • Mentor clinical data managers, support capabilities and bid defense meetings, and contribute to SOP and process improvements.

Requirements

  • Bachelor’s or Master’s degree in a scientific or healthcare field preferred, 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.
  • Excellent verbal and written communication, interpersonal, organizational, and independent problem-solving skills.
  • Must be remotely based within Mexico.

Culture & Benefits

  • Full-time employment with a remote work arrangement within Mexico.
  • Collaborative and inclusive work environment.
  • Opportunity to work across pharmaceutical, biotech, and medical device clinical research projects.
  • Support for professional learning and expanding drug development expertise.
  • CV must be submitted in English.

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