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14 часов назад

CRA 2, Single-Sponsor Dedicated

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
Netherlands
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
CRA 2, Single-Sponsor Dedicated (Clinical Research): Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials with an accent on GCP, patient safety, data integrity, and protocol compliance. Focus on managing site relationships, resolving study risks and data queries, optimizing patient recruitment, and maintaining inspection-ready documentation across the trial lifecycle.

Location: Amsterdam, Netherlands; candidates must be based in the Netherlands. Travel within the assigned region may reach 40–60% of working time.

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

  • Conduct site qualification, initiation, monitoring, and close-out visits in line with study protocols, GCP, ICH guidelines, and regulatory requirements.
  • Protect patient safety, data integrity, protocol compliance, and study quality at investigational sites.
  • Build relationships with investigators and site personnel and provide guidance, training, and ongoing study support.
  • Monitor recruitment, enrollment, regulatory documentation, data queries, site performance, and study progress.
  • Identify and escalate study risks and quality issues while driving timely resolution with cross-functional teams.
  • Maintain inspection-ready ISF, TMF, monitoring reports, follow-up communications, and other study documentation.

Requirements

  • Bachelor’s degree in life sciences, health sciences, nursing, pharmacy, or a related discipline, or an equivalent combination of education and experience.
  • At least 1.5 years of on-site clinical trial monitoring experience in a CRO, pharmaceutical, biotechnology, or healthcare environment.
  • Strong knowledge of GCP, ICH guidelines, and applicable regulatory requirements.
  • Fluent written and verbal Dutch at minimum C1 level, plus strong English communication skills.
  • Excellent communication, organization, stakeholder management, independent working, and prioritization skills.
  • Willingness to travel 40–60% within the assigned region and a valid Class B driver’s license.

Nice to have

  • Experience in a sponsor-dedicated or cFSP environment.
  • Knowledge of patient recruitment and study start-up activities.
  • Experience mentoring or supporting junior clinical team members.

Culture & Benefits

  • Work as an embedded member of a pharmaceutical or biotechnology sponsor team with the stability and infrastructure of hirify.global.
  • Structured training, mentorship, continuous professional development, and global career pathways.
  • Opportunities to work across clinical development phases and therapeutic areas.
  • A work environment focused on flexibility, continuous learning, wellbeing, expertise, and innovation.
  • Long-term career continuity as individual sponsor programs evolve.

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