14 дней назад
TMF Specialist (Clinical Research)
83 000 - 196 600PLN
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
TMF Specialist (Clinical Research) (Records Management/GCP): Managing Trial Master File review, records retrieval, filing compliance, and study transfers across complex clinical research projects with an accent on inspection readiness, regulatory requirements, and quality metrics. Focus on crosschecking TMF records, coordinating stakeholders and clients, training records management staff, and leading project processes.
Location: Hybrid in Warsaw, Poland
Annual base pay: zł83,000.00–zł196,600.00
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Serve as the liaison between Records Management and user departments for Trial Master File activities.
- Review TMF records, perform crosschecks and co-dependency checks, and maintain inspection readiness.
- Monitor filing accuracy, SOP compliance, deadlines, team outputs, and project quality metrics.
- Coordinate record retrieval, transfers, recalls, disposition, and preparation of closed studies for client handover.
- Act as a primary client contact and support records management projects, cost proposals, and resource planning.
- Train staff on records management processes and may lead project teams.
Requirements
- High school diploma or equivalent, with at least three years of experience in a Records Management environment.
- Strong knowledge of ICH, Good Clinical Practice, applicable local laws, regulations, and guidelines.
- Knowledge of technology applications used in records management environments.
- Strong analytical, organizational, planning, decision-making, communication, and prioritization skills.
- Good command of English is required, along with the ability to build effective relationships with internal and external clients.
- Ability to lead others and work with prolonged sitting, writing, and keyboarding requirements.
Culture & Benefits
- Full-time employment with a hybrid work arrangement.
- Work supporting clinical research, healthcare intelligence, and the development of medical treatments.
- Health and welfare benefits may be offered depending on the position.
- Incentive plans, bonuses, or other compensation may be available depending on the position.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
5 дней назад
Clinical Research Associate
113 000PLN
5 дней назад
Medical Affairs Scientist (Pharmaceuticals)
217 500PLN
3 дня назад
Principal Scientist, CMC Regulatory Affairs
205 000 - 354 200PLN
3 дня назад
Medical Science Liaison Associate (Oncology)
112 000 - 132 000PLN
5 дней назад
Senior Medical Writer/Principal Medical Writer
5 дней назад