9 дней назад
TMF Specialist - Hybrid (Bulgaria)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
TMF Specialist (Records Management/Clinical Research): Supporting Trial Master File operations across complex clinical research projects, sites, and teams with an accent on regulatory compliance, filing accuracy, and inspection readiness. Focus on reviewing TMF records, coordinating transfers and retrievals, training staff, and maintaining quality and timeline requirements.
Location: Hybrid, Sofia, Bulgaria
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Act as a liaison between Records Management and user departments regarding Trial Master Files.
- Review TMF records, perform crosschecks and co-dependency checks, and support inspection readiness.
- Monitor filing accuracy, SOP compliance, project deadlines, team outputs, and quality metrics.
- Coordinate record retrieval, transfer, recall, disposition, and preparation of closed studies for client delivery.
- Train team members on records management processes, policies, and procedures.
- Serve as a primary client contact and may lead records management projects.
Requirements
- High school diploma or equivalent.
- At least 3 years of experience in a Records Management environment, or an equivalent combination of education, training, and experience.
- 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. The role also requires prolonged sitting and frequent writing and keyboarding.
Culture & Benefits
- Hybrid work format in Sofia, Bulgaria.
- Work in a global clinical research and healthcare intelligence organization.
- Responsibilities include collaboration with internal departments, external clients, and project teams.
- Work is governed by documented SOPs, policies, regulatory requirements, and quality standards.
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