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1 час назад

Senior Data Management Associate (Clinical Data Management)

115 260 - 149 160$
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
Senior Data Management Associate (Clinical Data Management): Overseeing clinical data management for complex oncology and cell therapy studies from start-up to close-out with an accent on data quality, eCRF design, external data coordination, and regulatory compliance. Focus on leading cross-functional study deliverables, resolving clinical data queries, coordinating database snapshots, and managing vendor data processes.

Location: United States – Remote

Salary: $115,260–$149,160 per year, with potential discretionary bonus, stock-based long-term incentives, paid time off, and benefits.

Company

hirify.global is a biopharmaceutical company developing cancer immunotherapies, including CAR T-cell and TCR-engineered cell therapies.

What you will do

  • Oversee clinical data management studies from start-up through close-out across complex clinical development programs.
  • Coordinate with Clinical Operations, Biostatistics, Statistical Programming, Safety, Regulatory, investigators, and external vendors.
  • Lead eCRF preparation and design, protocol review, data management planning, and study timelines.
  • Ensure clinical data completeness, accuracy, consistency, quality, and regulatory compliance.
  • Manage query resolution, external data transfers, data cleaning, reporting, database snapshots, and analysis readiness.
  • Lead study projects independently, facilitate meetings, delegate work, and escalate project-level issues.

Requirements

  • High school diploma and 9+ years of data management experience; or a BS/BA and 5+ years; or an MS/MA and 3+ years; or a PhD and 2+ years.
  • Experience with web-based electronic data capture systems such as Medidata Rave.
  • Strong verbal, written, communication, interpersonal, presentation, and problem-solving skills.
  • Ability to manage multiple complex studies, changing priorities, timelines, deliverables, and cross-functional collaboration.
  • Knowledge of clinical data management processes, data quality practices, and regulatory compliance.
  • Must be based in the United States for this remote position.

Nice to have

  • Oncology clinical data management experience, including hematological cancers or cell therapy.
  • Scientific background and laboratory data-handling experience.
  • Knowledge of FDA, EMA, and ICH clinical trial, statistics, and data management guidelines.
  • Experience managing clinical data deliverables for regulatory submissions.
  • Familiarity with MedDRA and WHODD thesauri or dictionaries.

Culture & Benefits

  • Mission-driven work focused on developing cancer therapies and reducing the burden of chronic care.
  • Inclusive work environment that supports diverse perspectives and individual differences.
  • Company-sponsored medical, dental, vision, and life insurance plans.
  • Paid time off and potential annual bonus and stock-based long-term incentives.

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