Назад
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9 дней назад

TMF Specialist (Clinical Research)

19 400 - 35 300€
Формат работы
hybrid
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
Slovakia
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
TMF Specialist (Clinical Research) (TMF/Records Management): Managing Trial Master File review, records retrieval, filing compliance, and study transfers for clinical research projects with an accent on inspection readiness, regulatory compliance, and quality control. Focus on coordinating multiple projects and sites, training records management staff, supporting client transfers, and resolving crosscheck and co-dependency issues.

Location: Bratislava, Slovakia; hybrid work

Annual base pay: €19,400–€35,300

Company

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

What you will do

  • Act as the liaison between Records Management and user departments regarding Trial Master Files.
  • Review TMF content, including crosschecks and co-dependency checks, to support inspection readiness.
  • Monitor filing accuracy, compliance with file plans and SOPs, project deadlines, and daily team outputs.
  • Coordinate record retrieval, transfers, recalls, disposition, and preparation of closed studies for client delivery.
  • Serve as the primary client contact and support records management projects, resource planning, and cost proposals.
  • Train staff on records management processes, policies, and procedures and may lead project teams.

Requirements

  • High school diploma or equivalent, or an equivalent combination of education, training, and experience.
  • At least 3 years of experience in a Records Management environment.
  • Strong knowledge of ICH, GCP, applicable local laws, regulations, guidelines, and records management technology.
  • Ability to analyze problems, develop solutions, make decisions, manage competing priorities, and meet defined timelines.
  • Strong organizational, planning, communication, and relationship-building skills, including the ability to lead others.
  • Good command of English is required. The role also involves extensive writing, keyboarding, and prolonged sitting.

Culture & Benefits

  • Work in a hybrid arrangement in Bratislava.
  • Potential access to health, welfare, and other benefits.
  • Additional incentive plans, bonuses, or other compensation may apply depending on the position.
  • Work within a regulated clinical research environment focused on improving patient outcomes and population health.

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