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1 месяц назад

Clinical Data Manager

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

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TL;DR

Clinical Data Manager: Manage end-to-end clinical data management activities for assigned studies with an accent on data accuracy, integrity, and compliance with regulatory standards. Focus on designing CRFs and edit checks, overseeing data collection, cleaning, validation, and discrepancy management, and ensuring CDISC standards adherence.

Location: United States (Remote)

Company

hirify.global is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

  • Manage end-to-end clinical data management activities for assigned studies
  • Design and review CRFs and edit checks
  • Oversee data collection, cleaning, and validation processes
  • Perform data review, discrepancy management, and data reconciliation (e.g., SAE, lab data)
  • Coordinate with cross-functional teams including Clinical, Biostatistics, and Programming
  • Support database build, UAT testing, database lock, and generate data listings and reports
  • Ensure compliance with CDISC standards and regulatory guidelines

Requirements

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field
  • 3–5 years of experience in clinical data management within CRO/pharma
  • Hands-on experience with EDC systems (e.g., Medidata Rave, Oracle Clinical, Inform)
  • Strong understanding of GCP, ICH guidelines, and clinical trial processes
  • Familiarity with CDISC standards (SDTM)
  • Good knowledge of data validation and query management
  • Strong attention to detail and problem-solving skills

Culture & Benefits

  • Work for a single sponsor with security and career opportunities of a global CRO
  • Continuous training to maintain high competence and expertise
  • Emphasis on diversity, inclusivity, and equal opportunity
  • Low turnover rates due to strong company ethos and employee development

Hiring process

  • Submit CV for acknowledgement
  • Phone interview if requirements match
  • No individual replies for unsuccessful applications due to high volume

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