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1 день назад

Clinical Data Manager (Clinical Trials)

Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
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
Clinical Data Manager (Clinical Trials): Managing clinical trial data for Phase I–III studies with an accent on data quality, regulatory compliance, and cross-functional coordination. Focus on developing clinical data management documents, reviewing discrepancies, supporting EDC and database workflows, and ensuring trial data is delivered on time and within budget.

Location: United States; remote work supported

Company

Provides consulting and clinical research solutions for biotech, medical device, and pharmaceutical organizations across the product lifecycle.

What you will do

  • Serve as the primary clinical data management representative on multidisciplinary Phase I–III clinical trial teams.
  • Track and communicate data management metrics, including data entry status, query resolution, and query aging.
  • Review, develop, and write clinical trial documents such as Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans, and eCRF Completion Guidelines.
  • Coordinate with clinical database programmers on data flow charts, data transfer specifications, and import guidelines.
  • Perform data review and discrepancy resolution, support UAT and quality control activities, and archive trial documentation.
  • Provide training and guidance to sites, third-party vendors, and senior clinical data coordinators.

Requirements

  • At least 5 years of clinical data management experience.
  • Experience with Electronic Data Capture systems is required.
  • Bachelor’s degree or certification in a related allied health profession is preferred; equivalent experience may be considered.
  • Knowledge of ICH/GCP and applicable local and international clinical research regulations.
  • Experience in a CRO or CRO data management environment is preferred.
  • Project management experience within data management is preferred.

Nice to have

  • Experience with Oracle Inform EDC.
  • Oncology or inflammatory therapeutic area experience.

Culture & Benefits

  • Remote working is supported, with hybrid collaboration encouraged for employees located near an office.
  • Inclusive workplace focused on diversity, equity, and belonging.
  • Environment that encourages innovation, collaboration, and entrepreneurship.
  • Applications are reviewed personally by the recruitment team rather than AI screening tools.
  • Applicants receive an outcome on their application.

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