6 дней назад
TMF Document Specialist (Clinical Research)
83 000 - 196 600PLN
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
TMF Document Specialist (Clinical Research): Supporting study teams with Trial Master File quality checks, records management, and the imaging, transfer, retention, and disposition of clinical research records with an accent on regulatory compliance, filing accuracy, and project timelines. Focus on administering records management systems, coordinating retrieval and scanning processes, and maintaining record integrity under ICH, GCP, SOP, and local regulatory requirements.
Location: Hybrid in Warsaw, Poland
Salary: zł83,000–zł196,600 annualized base pay
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Provide Trial Master File quality-check assistance to study teams.
- Maintain complex project data and records management systems in line with project plans and timelines.
- Coordinate record retrieval, scanning, imaging, transfer, retention, disposition, and preparation of closed studies.
- Monitor filing accuracy and compliance with or customer file plans and Standard Operating Procedures.
- Train staff and team members on scanning, records management tasks, policies, and procedures.
- Act as a primary contact for internal and external clients while monitoring project outputs and deadlines.
Requirements
- Bachelor's degree or equivalent.
- 3–4 years of experience in a technically related records management area.
- Knowledge of ICH, GCP, clinical research regulatory requirements, and relevant local laws and guidelines.
- Knowledge of technology applications used in records center environments.
- Strong analytical, organizational, planning, decision-making, multitasking, and communication skills.
- Good command of English is required. The role also involves prolonged sitting, repetitive keyboarding, standing, walking, lifting or reaching, and occasional use of ladders for high-density file systems.
Culture & Benefits
- Full-time hybrid work arrangement in Warsaw.
- Work is governed by SOPs, policies, good clinical practices, and applicable regulatory requirements.
- Health and welfare benefits may be offered in addition to base pay.
- 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 →