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11 дней назад

Sr External Data Specialist (AI)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
c1
Страна
India
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
Sr External Data Specialist (Clinical Data Management/AI): Managing and processing external and local laboratory data throughout the clinical trial lifecycle with an accent on data quality, vendor transfers, regulatory compliance, and clinical database integrity. Focus on designing and validating external data workflows, reconciling laboratory results, and using AI, ML, and advanced analytics to identify discrepancies and mitigate data risks.

Location: Bangalore, Karnataka, India

Company

hirify.global provides clinical data services and the elluminate Clinical Data Cloud for life sciences organizations and digital clinical trials.

What you will do

  • Serve as the primary study contact and subject matter expert for external and local laboratory data processing.
  • Manage external vendor data transfers, agreements, specifications, reconciliation logs, change logs, and study start-up activities.
  • Review protocols, eCRF designs, vendor data, laboratory listings, and clinical database alignment.
  • Perform quality control of laboratory normal ranges, test transfers, exception listings, and patient-result linking.
  • Communicate data and validation issues to clinical data managers, study teams, vendors, clients, and project management.
  • Use clinical analytics technologies, AI, ML, and advanced analytics to monitor data, identify discrepancies, and support process improvements and training.

Requirements

  • Bachelor of Science or equivalent education, training, and directly related experience in a health-related field.
  • 5+ years of relevant experience, including considerable experience in a CRO or pharmaceutical environment.
  • Excellent command of English in written and verbal communication.
  • Knowledge of clinical data management processes, vendor data processing, external data types, data transfers, clinical data management systems, and electronic data capture systems.
  • Understanding of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, and basic medical terminology.
  • Strong collaboration, communication, leadership, mentoring, organizational, multitasking, and independent working skills.

Nice to have

  • Medical Laboratory Technology certificate.
  • Experience with various third-party vendors and external data methodologies.
  • Proficiency in Microsoft Office applications and demonstrated computer literacy.

Culture & Benefits

  • People-first organization with an inclusive culture that values diversity and individual experience.
  • Opportunities to learn, grow, and contribute to continuous improvement.
  • Work supporting digital transformation and the future of healthcare.

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