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4 дня назад

Director, Clinical Data Management (Biotech)

219 000 - 244 500$
Формат работы
hybrid
Тип работы
fulltime
Грейд
director
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
Director, Clinical Data Management (Biotech): Leading clinical data management strategy, systems, standards, and deliverables across multiple drug development programs with an accent on data quality, CDASH/SDTM/ADaM compliance, and CRO oversight. Focus on designing clinical data systems, applying AI and automation, managing inspection readiness, and delivering reliable data for analysis and regulatory submissions.

Location: US-based remote position with required minimum monthly or quarterly travel to the headquarters in Boston, Massachusetts; preference for New England-based candidates.

Salary: $219,000–$244,500 per year

Company

hirify.global is a clinical-stage biopharmaceutical company developing genetic medicines for neuromuscular and inherited retinal diseases, including Duchenne muscular dystrophy and myotonic dystrophy type 1 programs.

What you will do

  • Lead clinical data management strategy and deliverables across multiple drug development programs.
  • Develop and oversee data management plans, database designs, edit check specifications, and CRF completion guidelines.
  • Manage, mentor, and develop internal data management staff while overseeing CRO data management personnel.
  • Establish systems and processes that protect clinical data security, integrity, quality, and delivery timelines.
  • Lead CRO and vendor selection, contracting input, oversight, performance management, and budget management.
  • Represent clinical data management on cross-functional teams, regulatory inspections, audits, and senior leadership discussions.

Requirements

  • BS in computer science or a science-based discipline; an advanced degree is a plus.
  • 10+ years of industry clinical data management experience, including several years managing people or CRO data management teams.
  • Strong CRO vendor oversight, budget management, critical thinking, risk mitigation, and communication skills.
  • Proficiency with Medidata RAVE and other EDC platforms; experience with CluePoints, Spotfire, or similar data review tools.
  • Experience designing clinical trials using CDASH and SDTM terminology, with a strong understanding of FDA and ICH GCP guidelines.
  • Must be based in the United States; the role requires recurring travel to the Boston headquarters.

Nice to have

  • Programming experience.
  • Experience with regulatory GCP inspections and audits.

Culture & Benefits

  • Collaborative, fast-paced, and innovative environment focused on developing therapies for patients.
  • Health, dental, and vision coverage, life and disability insurance, and a 401(k) match.
  • Paid gender-inclusive parental leave and health and well-being support.
  • Education reimbursement, discretionary time off, and commuting benefits aligned to the working model.
  • Equal opportunity employment with support for a diverse workforce.

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