10 дней назад
TMF Quality Project Manager (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
TMF Quality Project Manager (Clinical Research): Managing Trial Master File and records management activities across clinical research projects, sites, and project teams with an accent on regulatory compliance, records integrity, and delivery against quality and timeline metrics. Focus on coordinating record transfers, retrieval, imaging, scanning, retention, disposition, and functional team leadership.
Location: Full home-based role in LATAM; Buenos Aires, Argentina
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 Files across multiple projects, sites, and project teams.
- Coordinate record retrieval, transfer, imaging, scanning, retention, recall, and disposition activities within agreed timelines.
- Monitor filing accuracy and compliance with or customer file plans, SOPs, GCP, and applicable regulatory requirements.
- Maintain records center security and oversee storage space, supplies, equipment, and disposal of obsolete records.
- Train staff and team members on records management, imaging, scanning, policies, and procedures.
- Act as the primary contact for internal and external clients and support project goals, cost proposals, and resource planning.
Requirements
- Bachelor’s degree in Records Management or a related field, or an equivalent combination of education, training, and experience.
- At least four years of experience in a technically related records management environment.
- Prior experience with Trial Master File oversight, review, or reconciliation across clinical studies.
- Knowledge of ICH, GCP, applicable local laws, regulations, guidelines, SOPs, and records management technologies.
- Strong problem-solving, organizational, planning, decision-making, communication, and multitasking skills.
- Solid command of English and the ability to work full home-based from LATAM are required.
Culture & Benefits
- Full home-based work arrangement for the LATAM region.
- Work across clinical research projects with internal departments and external clients.
- Structured work governed by SOPs, quality metrics, GCP, and applicable regulatory requirements.
- Opportunities to lead records management teams and contribute to strategic project planning.
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