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5 дней назад

Clinical Data Manager

Формат работы
remote (только Mexico/Brazil/Argentina)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Argentina/Chile/Mexico +3 еще
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Мэтч & Сопровод

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Описание вакансии

Текст:
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TL;DR
Clinical Data Manager (Clinical Trials): Managing clinical trial data from study start-up through post-database lock, with an accent on database development, data quality, regulatory compliance, and cross-functional coordination. Focus on designing CRF specifications, leading UAT and edit-check development, resolving data issues, and ensuring reliable clinical data delivery across LATAM studies.

Location: Remote in Mexico, Brazil, Argentina, Colombia, Chile, or Peru

Company

hirify.global supports clinical research and the development of innovative therapies through clinical data and trial management services.

What you will do

  • Lead clinical data management activities from study start-up through post-database lock for assigned projects and programs.
  • Develop CRF specifications, data-entry guidelines, edit-check requirements, and manual data-review specifications.
  • Oversee database builds, UAT, quality-controlled documentation, data review, query management, and clinical database quality.
  • Coordinate SAE/AE reconciliation, medical coding, status reporting, and study-level metrics.
  • Manage data-related timelines, resources, vendors, sponsors, and cross-functional project stakeholders.
  • Identify operational issues, support SOP development, train project teams, and contribute to proposals, estimates, and strategic initiatives.

Requirements

  • 8+ years of experience for Senior Clinical Data Manager level or 10+ years for Principal Clinical Data Manager level.
  • Bachelor’s degree and/or equivalent related experience.
  • Experience using various clinical database management systems.
  • Knowledge of drug, device, or biologic development and clinical data management practices.
  • Professional written and spoken English, strong organizational, communication, leadership, and interpersonal skills.
  • Proficiency with Microsoft Office and availability for occasional travel.

Nice to have

  • Clinical, scientific, or healthcare experience.
  • Medical coding experience with MedDRA and WHODrug.
  • Understanding of CDISC standards, including CDASH, SDTM, and ADaM.
  • Oncology or orphan drug therapeutic experience.

Culture & Benefits

  • Fully remote work within the listed LATAM countries.
  • Opportunity to help build the LATAM Data Management team.
  • Collaboration with sponsors, vendors, clinical research personnel, and cross-functional project teams.
  • Occasional travel and participation in strategy, client engagement, and project meetings.

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